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
Currently, the FDA recognizes hyperbaric oxygen therapy for 14 different conditions.
FDA clearance of a medical device includes a determination that the device has the same intended use as, and is as safe and effective as, another legally U.S.-marketed device of that type. As of July 2021, the FDA has cleared hyperbaric chambers for the following disorders:
- Air and gas bubbles in blood vessels
- Anemia (severe anemia when blood transfusions cannot be used)
- Burns (severe and large burns treated at a specialized burn center)
- Carbon monoxide poisoning
- Crush injury
- Decompression sickness (diving risk)
- Gas gangrene
- Hearing loss (complete hearing loss that occurs suddenly and without any known cause)
- Infection of the skin and bone (severe)
- Radiation injury
- Skin graft flap at risk of tissue death
- Vision loss (when sudden and painless in one eye due to blockage of blood flow)
- Wounds (non-healing, diabetic foot ulcers)
HBOT is being studied for other conditions, including COVID-19. However, at this time, the FDA has not cleared or authorized the use of any HBOT device to treat COVID-19 or any conditions beyond those listed above. The website, clinicaltrials.gov, has more information on HBOT clinical trials for COVID-19 and other conditions.
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
To the maximum extent permitted by law, Recovery for Athletes LLC, its directors, officers, employees, and affiliates shall not be liable for any indirect, incidental, special, consequential, exemplary, or punitive damages, including but not limited to loss of profits, goodwill, use, data, or other intangible losses, arising out of or relating to your use of the products or services.
In the event of any claim, dispute, or cause of action relating to or arising from a product purchased from Recovery for Athletes LLC, the customer’s sole and exclusive remedy shall be limited to the amount actually paid for the product in question.
Except as expressly stated by Recovery for Athletes LLC in writing, all products and services are provided “as is” and without warranties of any kind, whether express or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, or non-infringement.
These Terms shall be governed by and construed in accordance with the laws of North Carolina, without regard to conflict of law provisions. Any disputes shall be resolved exclusively in the state or federal courts located in Mecklenburg County, NC.
You agree to indemnify, defend, and hold harmless Recovery for Athletes LLC and its affiliates from any claims, liabilities, damages, losses, and expenses (including reasonable attorneys’ fees) arising out of your misuse of the product or breach of these Terms.
7. Questions?
If you have any questions about the FDA status of a specific product or would like further clarification:
Email: sales@recoveryforathletes.com