FDA Disclaimer

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.

1. 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.

2. 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.

3. 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.

4. 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
• Taking prescription medications

5. 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.

6. 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.

7. Questions?

For product-specific FDA status or if you need clarification on any point in this policy, please get in touch with us:

📧 support@recovathlete.com