FDA Disclaimer-Hyperbaric-Oxyrevo

OxyRevo Hyperbaric Chambers — Certifications & FDA Compliance

Our Commitment

At RecovAthlete, we believe in full transparency. We share this so you know exactly how our equipment fits within U.S. and international standards.

OxyRevo Certifications

OxyRevo chambers meet globally recognized safety and quality benchmarks for non-medical wellness use:

  • CE (Machinery Directive): EU compliance for non-medical machinery.
  • ISO 13485: Quality management system for medical-grade manufacturing.
  • Israeli Standard: National safety and performance compliance.
  • TÜV Certified: German inspection for quality and safety.

Note: OxyRevo chambers are not FDA-cleared for medical use in the United States. They are designed for wellness and recovery applications.

FDA Compliance Overview

Some recovery products on our site are FDA-cleared; others are FDA-registered or not evaluated by the FDA.

  • FDA-Cleared: Reviewed and approved for specific medical claims.
  • FDA-Registered: Manufacturer has notified the FDA of the product’s existence — this does not mean approval or endorsement.
  • Non-Approved: Not reviewed or cleared for medical use.

Hyperbaric Chambers & Off-Label Use

  • The FDA only clears soft chambers up to 1.3 ATA for altitude sickness.
  • Using them for wellness, athletic recovery, or chronic issues is off-label use — legal, but not FDA-evaluated for those purposes.
  • Chambers at 1.4–2.0 ATA (hard-shell units) are typically Class II medical devices requiring a prescription and PVHO-1 compliance in the U.S.

No Medical Claims

Unless stated for an FDA-cleared product:

  • The FDA has not evaluated products or statements on RecovAthlete.com.
  • Our products do not diagnose, treat, cure, or prevent any disease.
  • All content is for educational purposes only, not medical advice.

Consult a Healthcare Professional

Before starting any new recovery regimen or using our products for health conditions, consult a licensed provider — especially if you are:

  • Pregnant
  • Managing a medical condition
  • Taking prescription medication

Results May Vary

  • Outcomes depend on health, usage, and lifestyle.
  • We do not guarantee specific results.

Limitation of Liability

RecovAthlete and its affiliates are not liable for injury, harm, or adverse effects from the use or misuse of our products.
Users assume full responsibility for product use.

Questions?

Need details about a product’s certification or FDA status?
Contact us anytime — we’ll clarify everything.