FDA Compliance & Product Use Disclaimer
At RecovAthlete, we are deeply committed to transparency. We believe in empowering you with the information you need to make informed decisions. Some products are FDA-cleared, while others are not intended or marketed as FDA-approved medical devices.
FDA-Cleared vs. FDA-Registered vs. Non-Approved Products
Our selection includes recovery and wellness equipment that has received FDA clearance for specific medical uses. These products have undergone safety and effectiveness evaluations by the FDA.
Other items — such as soft hyperbaric chambers and performance technologies — may be FDA-registered but not FDA-cleared.
FDA registration means the manufacturer has notified the FDA of the product's existence.
It does not imply approval, endorsement, or evaluation for medical use.
In contrast, FDA clearance (or approval) means the product has passed FDA review for its intended medical claims.
Hyperbaric Chambers & Off-Label Use
The FDA has cleared soft hyperbaric chambers operating at 1.3 ATA only for treating altitude sickness.
Using these chambers for other purposes — such as general wellness, athletic recovery, or chronic condition management — is considered off-label.
Off-label use is not illegal, but it means the product's safety or effectiveness for that use has not been evaluated by the FDA, even if the chamber is FDA-registered.
Chambers operating at 1.4 to 2.0 ATA, especially hard-shell models, may be considered Class II medical devices and require a prescription and PVHO-1 compliance for legal sale and use in the U.S.
No Medical Claims
Unless explicitly stated otherwise for specific FDA-cleared products:
The FDA has not evaluated the products or statements on RecovAthlete.com.
Our products are not intended to diagnose, treat, cure, or prevent any disease.
All information provided is for educational and informational purposes, not a substitute for medical advice.
Consult a Healthcare Professional
We strongly encourage you to consult with a licensed healthcare provider before:
Starting any new recovery or wellness regimen
Using any equipment sold on our site for medical purposes
Treating existing conditions or symptoms
This is especially important if you are:
- Pregnant
- Managing a pre-existing medical condition
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Taking prescription medications
Results May Vary
Individual results will vary depending on your health, product use, and other lifestyle factors.
We do not make any claims of guaranteed results.
Limitation of Liability
RecovAthlete and its affiliates are not liable for any harm, injury, or adverse outcome resulting from using or misusing our products.
All users assume full responsibility for how they use our equipment.
Questions?
For product-specific FDA status or if you need clarification on any point in this policy, please get in touch with us:]
Certainly! Here’s an integrated piece that combines the detailed certifications of Oxyrevo hyperbaric chambers with a transparent FDA compliance and product use disclaimer, as you requested:
Oxyrevo Hyperbaric Chambers: Certifications & FDA Compliance Disclaimer
At RecovAthlete, we are deeply committed to transparency and your informed decision-making. Below, you’ll find both the certifications for Oxyrevo hyperbaric chambers and our comprehensive FDA compliance and product use disclaimer.
Oxyrevo Chamber Certifications
Oxyrevo hyperbaric chambers have received internationally recognized certifications, verifying their compliance with relevant safety and quality standards for non-medical and wellness use:
· CE (Machinery Directive): Confirms compliance with European Union safety standards for non-medical machinery.
· ISO 13485: Indicates conformity with the internationally recognized quality management system for medical devices.
· Israeli Standard: Certifies compliance with Israel’s safety and efficacy regulations.
· TÜV Certification: Issued by the German technical inspection body, showing adherence to safety and quality standards.
Note: Oxyrevo hyperbaric chambers are not FDA-cleared for medical use in the United States—they are designed mainly for wellness and non-medical applications.
FDA Compliance & Product Use Disclaimer
We believe in empowering you with the information you need to make informed decisions. The distinctions below clarify how FDA regulations apply to the wellness and recovery equipment available through RecovAthlete:
1. FDA-Cleared vs. FDA-Registered vs. Non-Approved Products
o Some recovery and wellness equipment has received FDA clearance for specific medical uses, having undergone FDA safety and effectiveness evaluation.
o Soft hyperbaric chambers (including Oxyrevo) may be FDA-registered but not FDA-cleared. FDA registration simply means the manufacturer has informed the FDA of the product; it does not imply FDA approval, endorsement, or evaluation for medical use.
o FDA clearance (or approval) means a product was reviewed by the FDA for specific medical claims.
2. Hyperbaric Chambers & Off-Label Use
o The FDA has cleared soft hyperbaric chambers operating at 1.3 ATA only for treating altitude sickness.
o Use for other purposes—such as general wellness, athletic recovery, or treating chronic conditions—is considered off-label. Off-label use is not illegal but has not been evaluated by the FDA for safety or effectiveness, even if the chamber is FDA-registered.
o Chambers operating at 1.4-2.0 ATA (especially hard-shell models) may be Class II medical devices, which in the U.S. require a prescription and PVHO-1 compliance for legal sale and use.
3. No Medical Claims
o Unless explicitly stated for an FDA-cleared product, the FDA has not evaluated the products or statements on RecovAthlete.com.
o Our products are not intended to diagnose, treat, cure, or prevent any disease. All information provided is for educational purposes only and is not a substitute for professional medical advice.
4. Consult a Healthcare Professional
o We strongly encourage consulting a licensed healthcare provider before:
§ Starting any new recovery or wellness regimen.
§ Using any equipment sold on our site for medical purposes.
§ Managing existing conditions or symptoms.
§ Consulting is especially important if you are pregnant, have a pre-existing medical condition, or take prescription medications.
5. Results May Vary
o Individual results depend on your health, how the product is used, and other personal factors. We do not guarantee results.
6. Limitation of Liability
o RecovAthlete and its affiliates are not liable for harm, injury, or adverse outcomes arising from the use or misuse of our products. Users assume full responsibility for their use of equipment.
7. Questions?
o For product-specific FDA status or clarification of this policy, please contact us.
Summary Table
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Certification
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Description
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CE (Machinery)
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Confirms compliance with EU safety standards for non-medical machinery
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ISO 13485
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Quality management system standard for medical devices
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Israeli Standard
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Compliance with Israel’s national safety and efficacy standards
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TÜV
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German technical inspection association certification for safety and quality
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Remember: Oxyrevo hyperbaric chambers are not FDA-cleared for medical applications in the U.S.; use for any medical purpose is considered off-label and should only be under the supervision of a licensed healthcare provider.
