At Recovery For Athletes, we are committed to transparency and believe in empowering you with the information you need to make informed decisions. Some products we sell are FDA-approved, while others are not intended or marketed as FDA-approved medical devices.
1. FDA-Approved vs. Non-FDA-Approved Products
Our curated selection of recovery and wellness equipment includes products that are FDA-approved for specific medical uses, ensuring your safety and peace of mind.
Other products — including certain soft hyperbaric chambers and wellness technologies — may be FDA-registered but not FDA-approved. Registration with the FDA indicates that the manufacturer has notified the FDA of the product’s existence; it does not imply approval or endorsement for medical use. In contrast, FDA approval means the product has undergone rigorous testing and evaluation by the FDA and is deemed safe and effective for its intended use.
2. Hyperbaric Chambers & Off-Label Use
The FDA has approved soft hyperbaric chambers operating at 1.3 ATA for treating altitude sickness.
Any use beyond this — including general wellness, recovery, performance enhancement, or treatment of chronic conditions — is considered off-label, even if the chamber is FDA-registered. Off-label use refers to using a product in a way that is not approved by the FDA. While it is not illegal, it is important to understand that the safety and effectiveness of the product for such uses have not been evaluated by the FDA.
3. No Medical Claims
Unless explicitly stated otherwise for specific FDA-approved products:
- The FDA has not evaluated the products and statements on recoveryforathletes.com.
- Our equipment is not intended to diagnose, treat, cure, or prevent any disease.
- Content on this website is for informational and educational purposes only and is not a substitute for medical advice.
4. Consult a Healthcare Professional
We strongly encourage all customers to speak with their healthcare provider before:
- Starting any new recovery regimen
- Using any equipment sold on our site
- Treating existing conditions or symptoms
This is especially important for individuals who are pregnant, have pre-existing conditions, or are using prescription medications.
5. Results May Vary
Individual experiences may differ based on health status, product use, and lifestyle factors. No claims are made regarding guaranteed outcomes.
6. Limitation of Liability
Recovery For Athletes and its affiliates are not liable for any harm or adverse effects resulting from using or misusing our products. Users assume full responsibility for their decisions.
7. Questions?
If you have any questions about the FDA status of a specific product or would like further clarification:
Email: sales@recoveryforathletes.com
Class II Medical Device Disclaimer
Disclaimer: By placing your order, you must agree to the statement below:
Intended Use & Important Considerations
- Medical Conditions: Our products are not intended to diagnose, treat, cure, or prevent any disease or medical condition. If you are seeking to address a specific medical concern, you should consult a qualified healthcare professional before use. Certain therapies and equipment used for medical purposes may be classified as regulated medical devices and may require a prescription or professional supervision — our products are not sold for those purposes.
- Wellness and Performance: Some customers choose to incorporate our products into their general wellness, recovery, or performance routines. Any such use is at the customer's own discretion and risk. We make no claims regarding therapeutic outcomes, and individual results may vary. Use should always be approached responsibly and in accordance with the product's instructions.
- Personal Use & Purchase: Customers are responsible for determining whether a product is appropriate for their individual needs and circumstances. We strongly recommend consulting with a licensed healthcare provider before beginning any new wellness routine, particularly if you have underlying health conditions, are pregnant, or are taking medications. By purchasing our products, you acknowledge that you have reviewed all product information and assume full responsibility for their proper and intended use.
Disclaimer: All products are sold for general wellness and personal use only. Statements made on this website have not been evaluated by the FDA. It is the buyer's responsibility to ensure safe and appropriate use, and to follow all manufacturer instructions and safety guidelines.
While a prescription is not always necessary, some insurance providers may require one if you are looking for reimbursement. Moreover, consulting with a healthcare provider before use is advised to ensure it suits your condition.