Medalite, Inc. — LED Mask Safety Waiver & Consent Agreement

MANDATORY SAFETY CHECKLIST (Required)

Use Medalite only if EVERY statement below is TRUE. 

■ I am 18 years or older.

■ I have no personal or family history of epilepsy, seizures, or photosensitive epilepsy.

■ Flickering lights, screens, or strobe lights have never caused me twitching, confusion, dizziness, blackout, absence episodes, or any unusual symptoms.

■ I have not experienced unexplained blackouts, sudden jerking movements upon waking (“morning jerks”), absence seizures, or loss of consciousness.

■ I have never had a brain injury, traumatic brain injury, brain surgery, brain tumor, or other neurological condition.

■ I am not pregnant or breastfeeding.

■ I am not sleep-deprived (less than 6 hours sleep in the last 24 hours) and not withdrawing from alcohol, sedatives, or other substances.

■ I am not taking medication known to lower seizure threshold OR I have written medical clearance from my prescribing physician to use light-flicker devices.

■ I am not currently experiencing psychosis, severe panic, dissociation, or active symptoms of severe mental illness.

■ I am not currently experiencing suicidal thoughts, urges, or plans.

■ If I am experiencing suicidal ideation, I understand that Medalite may ONLY be used under the direct, real-time supervision and responsibility of a licensed medical professional.

■ I have read and understood all Medical Risk Information and contraindications.

■ I understand this is a general wellness device, not a medical treatment.

1) Product Purpose & Non-Medical Disclaimer

The Medalite LED Mask is a general wellness device designed for relaxation, meditation enhancement, and self-exploration. It is NOT a medical device and has NOT been cleared, approved, or evaluated by the FDA for safety or effectiveness for any medical condition.

NO MEDICAL CLAIMS: Medalite, Inc. makes no claims that this device diagnoses, treats, cures, prevents, or mitigates any disease, medical condition, or mental health disorder. This device is not intended for therapeutic use.

VARIABLE RESULTS: Individual responses vary significantly. Some users report intense visual effects, deep relaxation, or enhanced meditation; others experience minimal effects. Both responses are normal and expected.

2) Safe-Use Guidelines

Environment: Use only while seated or lying down in a quiet, secure, supervised space. Never use while standing, walking, or in unstable environments.

Eyes Closed: Keep eyelids closed at all times when lights are active. Never open eyes during operation.

Start Conservative: Begin with Static or Slow Fade modes, lowest brightness settings, and shortest durations (5-10 minutes maximum initially).

Critical Flicker Warning: Avoid continuous flicker frequencies between 15-70 Hz, particularly 40 Hz, unless you are certain you have no photosensitivity. These frequencies pose the highest seizure risk.

Immediate Cessation: Remove mask immediately if you experience dizziness, anxiety, nausea, disorientation, confusion, muscle twitching, unusual sensations, or any distress.

Transportation Safety: Never use within 2 hours before operating vehicles, machinery, or equipment requiring alertness.

Substance Interactions: Medalite, Inc. does not condone illegal drug use. If combined with any psychoactive substances (including legal prescription medications), this must occur only where legally permitted and under licensed medical supervision with appropriate emergency protocols.

Inspection Before Use: Do not use the device if it appears damaged, modified, or defective. If so, discontinue use and contact Medalite for support. Do not attempt to repair or modify the device.

3) Medical Contraindications & Drug Interactions

Seizure-Lowering Medications include but are not limited to: • Antidepressants (bupropion, SSRIs, tricyclics) • Antibiotics (fluoroquinolones, penicillins) • Stimulants (amphetamines, methylphenidate) • Opioids and pain medications (tramadol, fentanyl) • Antihistamines, decongestants • Anti-malarial drugs • Some supplements and herbal remedies

This list is not exhaustive. Review complete list at medalite.io/contraindications and consult your prescribing physician before use if taking ANY medications.

4) Assumption of Risk & Release of Liability

I UNDERSTAND AND VOLUNTARILY ASSUME ALL RISKS associated with using the Medalite LED Mask, including but not limited to:

• Seizures, including photosensitive epileptic seizures

• Physical injury from falls or muscle spasms

• Psychological distress, panic attacks, or exacerbation of mental health conditions

• Triggering of traumatic memories or dissociative episodes

• Headaches, eye strain, or visual disturbances

• Unknown long-term effects

• Equipment malfunction

• Injury during supervised clinical or group settings

RELEASE OF LIABILITY: To the fullest extent permitted by Utah law and the laws of my state of residence, I hereby RELEASE, WAIVE, DISCHARGE, and COVENANT NOT TO SUE Medalite, Inc., its officers, directors, employees, agents, contractors, distributors, retailers, affiliates, successors, and assigns (collectively, the “Released Parties”) from any and all liability, claims, demands, actions, or causes of action arising from or related to:

1. My use of the Medalite device

2. Any injury, loss, or damage resulting from ordinary negligence

3. Reliance on instructions, warnings, or safety information provided

4. Use in clinical, therapeutic, or group wellness settings

EXCEPTIONS: Nothing in this waiver limits Medalite, Inc's obligations under applicable product liability law for manufacturing defects.

This waiver also does not release claims for:

• Gross negligence

• Willful misconduct

• Intentional torts

• Violations of consumer protection laws where such releases are prohibited

Users and clinics acknowledge and accept that ordinary risks inherent in light-flicker experiences (such as dizziness, eye strain, nausea, visual phenomena, or in rare cases photosensitive seizures) are voluntarily assumed. Users and clinics acknowledge that knowingly using a device that appears damaged, modified, or defective is at their own risk, and that Medalite, Inc. is not responsible for injuries or issues arising from normal wear-and-tear, misuse, or failure to follow instructions.

5) Indemnification

I agree to INDEMNIFY, DEFEND, and HOLD HARMLESS Medalite, Inc. and all Released Parties from any loss, liability, damage, cost, or expense (including reasonable attorneys' fees and court costs) arising from: (a) My breach of this Agreement (b) My misuse of the device contrary to instructions (c) My use of the device while under contraindicated conditions (d) Claims brought by third parties related to my use of the device (e) My violation of applicable laws or regulations

6) Arbitration & Dispute Resolution

BINDING ARBITRATION: Any dispute, claim, or controversy arising under this Agreement shall be resolved through binding individual arbitration under the American Arbitration Association Consumer Arbitration Rules, conducted in Salt Lake County, Utah.

CLASS ACTION WAIVER: I WAIVE ANY RIGHT to participate in class action lawsuits or class-wide arbitration against Medalite, Inc. All disputes must be brought individually.

EXCEPTIONS: This arbitration clause does not apply to:

• Claims for emergency injunctive relief

• Small claims court actions within jurisdictional limits

• Claims that cannot legally be subject to arbitration

7) Electronic Signature & Record-Keeping

By selecting "I AGREE" below: • I confirm EVERY item in the Safety Checklist is true for me today • I acknowledge reading and understanding this entire Agreement • I consent to electronic delivery under the ESIGN Act and Utah UETA • I understand this creates a legally binding contract • Medalite, Inc. may store my acceptance timestamp, IP address, device identifiers, and waiver version as proof of consent • I may request a copy by emailing contact@medalite.io • Electronic consent withdrawal does not affect previously executed agreements

8) Governing Law & Jurisdiction

This Agreement is governed by Utah state law without regard to conflict of laws principles. For any disputes not subject to arbitration, I consent to exclusive jurisdiction in state or federal courts located in Salt Lake County, Utah.

Multi-State Enforcement: Where state laws provide greater consumer protections that cannot be waived, those protections remain in effect. This Agreement shall be interpreted to comply with applicable consumer protection laws.

9) Severability & Modification

If any provision is deemed unenforceable, the remainder remains in full force. Medalite, Inc. may update this Agreement; continued use constitutes acceptance of modifications.

10) Privacy & Data Collection

Medalite collects minimal data necessary for service delivery and legal compliance. Personal health information entered during setup is stored locally on your device and NOT transmitted to our servers.

Full Privacy Policy: medalite.io/privacy

11) Clinical Use Addendum

For Supervised Therapeutic Settings Only

When used in therapeutic or medically supervised settings (including but not limited to psychedelic-assisted therapy, mental health treatment, or other clinical interventions), the following additional terms apply:

Medical Oversight: The supervising clinic, provider, or facilitator assumes primary responsibility for patient safety monitoring, and all treatment decisions remain the responsibility of licensed providers.

Adjunctive Tool Only: Medalite is a non-medical sensory enhancement tool. All medical treatment decisions remain with licensed providers.

Enhanced Supervision Required: Clinical use requires:

• Pre-screening for photosensitivity and contraindications

• Continuous visual monitoring during sessions

• Immediate device removal capability

• Emergency medical protocols in place

• Patient remains seated/reclined throughout use

• Session documentation in medical records

Expanded Consent: Patients with depression, anxiety, or suicidal ideation may use Medalite under direct medical supervision, with the supervising provider assuming responsibility for safety assessment and monitoring.

Clinical Liability Allocation:

• Clinics and providers remain responsible for patient screening, supervision during use, maintaining appropriate insurance coverage, and adherence to applicable standards of care.

• Medalite, Inc. remains responsible for ensuring its devices are reasonably safe when used as instructed and free from manufacturing defects that materially affect user safety.

12) References

• Epilepsy Foundation: Photosensitive Seizures Guidelines

• FDA General Wellness Policy (21 CFR 820)

• Utah Uniform Electronic Transactions Act

• Federal ESIGN Act (15 U.S.C. § 7001)

• American Arbitration Association Rules

• Utah Consumer Protection Act

Privacy Policy | Contraindications