Medical Disclaimer

IMPORTANT MEDICAL DISCLAIMER

Please read this Medical Disclaimer carefully before using the Erchonia-DPN website or using an Erchonia® DPN Laser furnished to you by your healthcare provider.

The information available through this website is intended for general educational and informational purposes only.

1. Informational Purposes Only

Information provided on this website, including text, graphics, videos, animations, frequently asked questions, educational materials, clinical-study information, downloadable resources, product information, and other content, is provided for general informational and educational purposes.

Nothing on this website is intended to constitute:

• Medical advice
• A medical diagnosis
• A prescription
• A recommendation for treatment
• A determination that treatment is appropriate for any particular person
• A substitute for consultation with a qualified healthcare professional
• A guarantee of treatment eligibility
• A guarantee of treatment results

Always consult your physician or another qualified healthcare professional regarding any medical condition and before beginning, changing, extending, or discontinuing treatment.

Do not disregard professional medical advice or delay seeking medical attention because of information obtained from this website.

2. Erchonia Does Not Practice Medicine

Erchonia Corporation, LLC ("Erchonia") is a medical device manufacturer and fulfillment and logistics provider.

Erchonia does not:

• Practice medicine
• Diagnose diseases or medical conditions
• Evaluate patients
• Select patients for treatment
• Determine whether treatment is medically appropriate
• Prescribe treatment
• Determine treatment duration
• Determine whether treatment should be extended
• Provide medical advice or medical opinions
• Provide patient-specific treatment instructions
• Provide clinical monitoring or follow-up
• Direct or control the practice of medicine
• Establish a physician-patient relationship

All clinical decisions concerning use of the Erchonia-DPN Laser are made solely by licensed healthcare professionals exercising their independent professional judgment.

The prescribing clinic or healthcare provider is solely responsible for patient evaluation, diagnosis, patient selection, informed consent, prescribing, treatment duration, treatment instructions, contraindication screening, monitoring, adherence, follow-up, and all other aspects of patient care.

Erchonia's manufacture, configuration, supply, fulfillment, shipment, replacement, recovery, or receipt of an Erchonia-DPN Device does not constitute the practice of medicine or approval of any individual clinical decision.

3. Independent Healthcare Providers

Healthcare providers and clinics participating in the Erchonia-DPN program exercise independent professional judgment regarding their patients.

Erchonia does not supervise, direct, employ, or control a healthcare provider's clinical decision-making.

A healthcare provider's use of Erchonia products or participation in the Erchonia-DPN fulfillment program does not make that provider an employee, agent, or representative of Erchonia for purposes of patient care or clinical decision-making.

The healthcare provider and clinic remain solely responsible for the professional services they provide to their patients.

Erchonia's fulfillment of an order should not be interpreted as confirmation that Erchonia has reviewed or approved the patient's diagnosis, prescription, treatment plan, treatment duration, or medical appropriateness for treatment.

4. FDA-Cleared Prescription Medical Device

The Erchonia® DPN Laser, Model EVRL, is a prescription medical device cleared by the U.S. Food and Drug Administration under 510(k) No. K251903.

Its cleared indication for use is:

The Erchonia® DPN Laser is indicated while using the red and violet diode simultaneously for prescription home use as an adjunctive treatment in providing temporary relief of diabetic peripheral neuropathy foot pain.

FDA clearance does not mean that treatment is guaranteed to work for every patient or that every patient will experience the same result.

The Erchonia-DPN Laser is not represented as:

• Curing diabetic peripheral neuropathy
• Curing diabetes
• Preventing progression of diabetes or neuropathy
• Eliminating the need for ongoing medical care
• Guaranteeing reduction of pain
• Producing any specific result for an individual patient

Use of the Device must be directed by a licensed healthcare provider.

5. Prescription and Independent Clinical Decision Required

The Erchonia-DPN Laser is a prescription-use medical device.

Before a participating clinic furnishes a Device to a patient, the clinic and its licensed healthcare provider are responsible for:

• Evaluating the patient
• Determining whether treatment is medically appropriate
• Screening for applicable contraindications, warnings, and precautions
• Prescribing and directing the Course of Treatment
• Determining treatment duration
• Providing necessary patient instruction
• Obtaining applicable informed consent
• Obtaining applicable patient acknowledgments
• Monitoring and following the patient as clinically appropriate

Erchonia does not perform these functions.

An Erchonia fulfillment order does not constitute a prescription, medical approval, determination of medical necessity, or endorsement of the clinic's treatment decision.

6. Standard Device Configuration

Devices supplied through the Erchonia-DPN fulfillment program are configured by Erchonia to the applicable Standard Program.

Erchonia does not configure, program, or modify a Device to correspond to an individual patient's:

• Prescription
• Treatment duration
• Prescribed end date
• Medical condition
• Clinical circumstances
• Individual treatment plan

The prescribing healthcare provider remains solely responsible for directing how the Device is used by the patient in accordance with the provider's independent professional judgment and applicable law.

Erchonia's configuration of the Device should not be interpreted as a treatment recommendation for any individual patient.

7. Fulfillment Period Is Not Treatment Duration

For fulfillment and logistics purposes, a Device may be assigned a fixed Fulfillment Period and a printed "Return by" date.

The Fulfillment Period and "Return by" date are logistics dates only.

They do not constitute:

• A prescription
• A recommended treatment duration
• A determination of medical necessity
• A clinical recommendation
• Authorization to continue treatment until the printed date

A patient's actual Course of Treatment and prescribed end date are determined solely by the patient's licensed healthcare provider.

A patient's applicable Device return deadline may therefore occur before the printed "Return by" date if the patient's prescribed Course of Treatment ends earlier.

Patients should follow their healthcare provider's treatment instructions regardless of the logistics dates associated with the Device.

8. Individual Results May Vary

Individual treatment results vary.

Clinical outcomes may be influenced by numerous factors, including a patient's medical condition, disease history, overall health, adherence to the prescribed Course of Treatment, concurrent conditions, medications, and individual biological response.

Clinical results or statistics presented on this website describe study findings or other available information concerning the Device and do not guarantee or predict a particular patient's outcome.

Nothing on this website constitutes a promise, warranty, or guarantee of clinical success.

9. No Physician-Patient Relationship With Erchonia

Accessing this website, reviewing information about the Erchonia-DPN Laser, receiving a Device shipped by Erchonia at a clinic's direction, communicating with Erchonia about shipment or return logistics, or communicating with Erchonia about a product issue does not establish a physician-patient relationship between Erchonia and any individual.

A patient's healthcare relationship is with the healthcare provider or clinic responsible for evaluating, prescribing, directing, and monitoring treatment.

Erchonia is not a party to that physician-patient relationship.

10. Device Fulfillment and Direct Shipment

Participating clinics may direct Erchonia to ship an Erchonia-DPN Device directly to a patient's Delivery Address.

Erchonia performs this shipment as a fulfillment and logistics service for the clinic.

Direct shipment of a Device to a patient does not mean that Erchonia:

• Prescribed the Device
• Selected the patient
• Evaluated the patient
• Approved treatment
• Determined treatment duration
• Furnished medical care
• Established a physician-patient relationship
• Sold or rented the Device to the patient

Upon delivery, the Device is furnished by the participating clinic to its patient as practice equipment for home use as an incident of the clinic's prescribed Course of Treatment.

11. No Patient Device Rental or Sale by Erchonia

The Erchonia-DPN fulfillment program is not a sale, rental, or lease of a Device from Erchonia to the patient.

Erchonia does not charge patients:

• Device rental fees
• Per-day Device fees
• Per-treatment Device fees
• Deposits
• Purchase-conversion fees

Any professional fees charged by a clinic to its patient are independently determined by the clinic.

Erchonia does not establish those fees and does not receive a percentage of the clinic's patient revenue.

Title to the Device remains with Erchonia.

12. Patient Use and Clinical Responsibilities

Patients should:

• Follow the prescribing healthcare provider's instructions
• Read and follow applicable instructions and labeling accompanying the Device
• Use the Device only as directed by their healthcare provider
• Use required protective eyewear
• Care for and handle the Device appropriately
• Use only the Device login passcode provided by their clinic
• Not attempt to access or alter restricted Device settings
• Immediately stop use and contact their healthcare provider if instructed to do so or if a concerning medical issue arises
• Promptly report injuries, adverse events, unexpected reactions, or clinical concerns to their healthcare provider
• Return the Device according to applicable return instructions

Questions about treatment duration, symptoms, medications, medical conditions, treatment continuation, treatment frequency, treatment results, or whether treatment should stop should be directed to the patient's healthcare provider, not Erchonia.

13. Device Malfunctions, Product Complaints, and Adverse Events

Patients may contact Erchonia customer service regarding:

• Shipping damage
• Missing Device components or accessories
• Device malfunctions
• Replacement Return Kits
• Replacement prepaid return labels
• Return logistics
• Carrier pickup

Erchonia may provide non-clinical troubleshooting related to fulfillment or Device functionality and may arrange permitted replacement and return logistics.

Erchonia does not provide medical advice or patient-specific treatment instruction.

Patients should direct the following to their prescribing clinic or healthcare provider:

• Injuries
• Adverse events
• Unexpected medical reactions
• New or worsening symptoms
• Questions about whether treatment should continue
• Questions regarding medical conditions or medications
• Other clinical concerns

Participating clinics are responsible for reporting applicable complaints and adverse events to Erchonia as required by the applicable agreement and law.

Erchonia may collect, use, and maintain information reasonably necessary to investigate product complaints, adverse events, Medical Device Reports, recalls, corrections, removals, field safety actions, and other regulatory or product-safety matters.

14. Direct Communications From Erchonia

Erchonia may communicate directly with a patient for limited non-clinical purposes permitted under the Erchonia-DPN program, including:

• Shipment notifications
• Delivery notifications
• Confirming or correcting a Delivery Address following a failed delivery
• Reshipment logistics
• Return logistics
• Providing replacement return materials
• Scheduling carrier pickup
• Device-recovery logistics
• Shipping damage
• Missing items
• Device malfunction
• Product-safety matters
• Recalls, corrections, removals, or field safety actions
• Communications otherwise required by law

These communications do not establish a physician-patient relationship and should not be interpreted as medical advice or treatment direction.

Erchonia does not use these communications to prescribe treatment, determine treatment duration, or communicate an Erchonia Device charge, fee, price, or financial consequence to the patient.

15. Return of the Device

Patients are responsible for returning Erchonia-owned Devices according to the applicable instructions provided through their clinic and the Patient Custody Acknowledgment.

A Device generally must be returned by the earlier of:

• The applicable printed "Return by" date; or
• The return deadline associated with the clinic's prescribed Course of Treatment

Unused treatment sessions do not extend the applicable return deadline.

Patients may contact Erchonia for permitted assistance with replacement return materials or carrier pickup.

Return requirements concern custody of Erchonia-owned equipment and do not determine how long a patient should receive treatment.

16. Multiple Devices

A healthcare provider may independently determine that a patient should receive more than one Device during a Course of Treatment, subject to applicable law and the applicable Clinic Agreement.

Erchonia's fulfillment of an additional Device order is a fulfillment act only.

It does not constitute:

• A recommendation for additional treatment
• Approval of extended treatment
• A determination of medical necessity
• An endorsement of the healthcare provider's clinical decision

When multiple Devices are furnished, the clinic is responsible for instructing the patient regarding their use.

Devices furnished under the program are intended to be used sequentially and not concurrently where required by the applicable program documents.

Each Device remains subject to its own applicable return requirements.

17. New or Reprocessed Devices

Devices furnished through the Erchonia-DPN program may be new or previously used and reprocessed by Erchonia.

Returned Devices may undergo applicable:

• Cleaning
• Disinfection
• Inspection
• Functional verification
• Other appropriate reprocessing procedures

Participating clinics are responsible for providing their patients with required disclosures concerning Device custody and the potential receipt of previously used and reprocessed equipment.

Receipt of a reprocessed Device does not change the patient's clinical relationship with the prescribing clinic.

18. Off-Label Use

Erchonia does not promote or recommend use of the Erchonia-DPN Laser outside its FDA-cleared labeling.

A licensed healthcare provider may make independent clinical decisions concerning an individual patient subject to applicable law and professional standards.

Any such decision is made solely by the healthcare provider and is not a recommendation, authorization, approval, or endorsement by Erchonia.

Erchonia's acceptance or fulfillment of an order, including an order for an additional Device, should not be interpreted as approval or endorsement of an Off-Label Use or extended Course of Treatment.

Nothing on this website is intended to encourage or promote Off-Label Use.

19. Device Settings and Access Controls

Erchonia controls restricted Device settings necessary to maintain the Standard Program.

Clinics and patients should not attempt to:

• Access restricted Device settings
• Disable the DPN mode
• Change treatment limits
• Reset treatment counts
• Modify Device configuration
• Obtain or use Erchonia's restricted settings passcode

The clinic provides the patient with the applicable Device login passcode used for ordinary operation.

The Device's technical configuration does not replace or determine the prescribing provider's clinical instructions.

20. Not Emergency Medical Care

The Erchonia-DPN website and fulfillment program are not intended for emergency medical care.

Do not use this website or contact Erchonia for treatment of a medical emergency.

If you believe you are experiencing a medical emergency, contact emergency medical services or seek immediate care from an appropriate healthcare facility.

21. Website and Educational Content

Erchonia seeks to provide accurate and appropriate information concerning its products, FDA clearance, clinical studies, instructions for use, and related topics.

Medical knowledge, regulatory requirements, product information, and applicable labeling may change over time.

Website content may therefore be modified, supplemented, or updated.

Healthcare professionals and patients should refer to current applicable labeling and instructions for use and consult qualified healthcare professionals regarding clinical decisions.

22. No Guarantee of Outcomes

Erchonia makes no warranty or guarantee concerning:

• Whether a particular patient will respond to treatment
• The amount of pain reduction a patient may experience
• How quickly a patient may experience a response
• Whether an improvement will continue after treatment
• Whether additional treatment will be appropriate
• Whether an individual patient is an appropriate candidate
• Any other patient-specific clinical outcome

Clinical decisions and expectations should be discussed with the prescribing healthcare provider.

23. Limitation of Medical Responsibility

To the fullest extent permitted by applicable law, Erchonia is not responsible for medical decisions made independently by healthcare providers, including:

• Diagnosis
• Patient selection
• Medical necessity
• Prescribing decisions
• Treatment duration
• Treatment instructions
• Clinical monitoring
• Follow-up
• Off-label medical decisions
• Failure to identify contraindications or precautions
• Medical malpractice or professional negligence
• Patient compliance with clinical instructions

Nothing in this Section limits liability that cannot lawfully be excluded or limited, including applicable responsibility for Erchonia's own conduct or product obligations.

24. Product and Manufacturer Responsibility

Nothing in this Medical Disclaimer eliminates or limits responsibilities applicable to Erchonia in its role as a medical device manufacturer where those responsibilities cannot lawfully be disclaimed.

Erchonia remains responsible for applicable obligations concerning:

• Product quality
• Device manufacturing
• Product complaints
• Medical Device Reporting
• Regulatory reporting
• Recalls
• Corrections and removals
• Field safety actions
• Other applicable manufacturer responsibilities

The allocation of clinical responsibility to participating healthcare providers does not eliminate Erchonia's independent legal or regulatory obligations as a medical device manufacturer.

25. Patient Custody Acknowledgment

Before a participating clinic submits an order, the clinic is responsible for obtaining the applicable Patient Custody Acknowledgment from the patient.

The Patient Custody Acknowledgment governs certain matters concerning the patient's possession, care, handling, use, and return of the Device.

The Patient Custody Acknowledgment is between the clinic and the patient.

Erchonia is not a party to the Patient Custody Acknowledgment.

Nothing in that acknowledgment creates a physician-patient relationship between Erchonia and the patient.

26. Relationship to Other Agreements and Policies

This Medical Disclaimer describes Erchonia's role and provides general information concerning the Erchonia-DPN program.

It does not replace:

• The clinical relationship between a patient and healthcare provider
• The clinic's informed-consent process
• The Patient Custody Acknowledgment or other patient documents provided by the clinic
• FDA-cleared labeling or applicable instructions for use
• Erchonia's Privacy Policy
• Erchonia's HIPAA & Protected Health Information Notice
• Erchonia's Terms of Use
• The applicable Business Associate Agreement
• Any executed agreement between Erchonia and a participating clinic

Where an executed Clinic Agreement governs the relationship between Erchonia and a participating clinic, that agreement controls according to its terms.

With respect to PHI matters, the applicable Business Associate Agreement controls according to its terms.

27. Changes to This Disclaimer

Erchonia may update this Medical Disclaimer periodically to reflect changes in:

• Applicable law or regulation
• Product information or labeling
• Website functionality
• Program operations
• Fulfillment procedures
• Business operations

The current version will be posted on the Erchonia-DPN website with its effective date.

Changes to this website Medical Disclaimer do not amend an executed agreement between Erchonia and a participating clinic.

28. Contact Information

Questions regarding this Medical Disclaimer may be directed to:

Erchonia Corporation, LLC
112 Southchase Boulevard
Fountain Inn, South Carolina 29644

Email: info@erchonia.com
Phone: (888) 242-0571

Effective Date: August 24, 2026