FDA Disclaimer

Last updated: October 2026

In short: Wellness Territory sells wellness and recovery equipment made by other companies. We do not claim that any product diagnoses, treats, cures or prevents a disease, and we are not the manufacturer. Regulatory status differs from product to product and brand to brand, so please read the manufacturer's labeling and talk to your physician before you buy or use anything.

FDA statement

The statements on this website have not been evaluated by the U.S. Food and Drug Administration (FDA). Products sold by Wellness Territory are not intended to diagnose, treat, cure or prevent any disease or medical condition. Nothing on this site is medical advice.

Regulatory status varies by product

Wellness and recovery equipment is regulated in different ways. Some products, such as certain hyperbaric chambers, are regulated as medical devices and may require a prescription. Others, such as many red light devices, cold plunges and saunas, are sold for general wellness or recreation. We rely on information supplied by each manufacturer.

• If a manufacturer tells us a product is FDA cleared or prescription-only, we try to say so on the product page.
• If a listing does not mention FDA clearance, please do not assume the product has been cleared or approved. Ask the manufacturer or contact us.
• FDA clearance applies only to the uses stated in the manufacturer's labeling. It does not mean the FDA has reviewed any other use.

Manufacturer certifications and registrations

Some manufacturers publish company-level certificates, such as ISO 13485 and ISO 9001 quality management certificates, RoHS attestations and FDA establishment registrations. We show these on the product pages where the manufacturer provides them.

• These certificates are issued to the manufacturer as a company, not to an individual model unless the certificate says so.
• An FDA establishment registration or device listing is not FDA approval or clearance. It means the facility is registered with the FDA. It does not mean the FDA has reviewed, cleared or approved a product, and the FDA does not endorse registered facilities.
• ISO and RoHS certificates describe quality management systems and material restrictions. They are not statements about health outcomes.

Product categories

Hyperbaric chambers

A hyperbaric chamber is a pressurized, oxygen-enriched environment. The FDA has cleared hyperbaric chambers for a specific list of medical conditions, delivered under medical supervision. We do not make claims about other uses. Where a manufacturer requires a prescription, we may need to collect it before we can ship your order. Keep flames, sparks and heat sources away from the chamber and any oxygen equipment, and follow the manufacturer's manual at all times.

Cryotherapy chambers and devices

Cryotherapy involves extreme cold. The FDA has cautioned consumers about claims that whole-body cryotherapy treats medical conditions. The equipment we list is generally intended for trained operators and commercial or professional settings. Follow the manufacturer's training, screening and safety requirements.

Red light and near-infrared devices

Our listings describe red light devices as intended for general wellness use, following the manufacturer's instructions. Use the supplied eye protection and follow the manufacturer's guidance on distance, session length and frequency.

PEMF and electrical stimulation products

PEMF mats and applicators and EMS suits are classified and labeled in different ways. Do not use them with a pacemaker or other implanted electronic device, or during pregnancy, unless your physician approves.

Hydrogen water and water treatment

Hydrogen-enriched water is a beverage, not a medicine. Water systems perform according to your source water and correct installation and maintenance.

Product descriptions and customer content

Product descriptions are based on information from the manufacturer. Reviews and customer experiences on this site reflect individual opinions, are not medical claims and do not guarantee results. Results vary.

Talk to your physician

Check with a qualified healthcare professional before you buy or use any of our products, especially if you have a medical condition, take medication, have an implanted medical device, are pregnant or are buying for a child. See also our general disclaimer.

Reporting a problem

If you experience a serious problem with a product, stop using it, get medical help if you need it, and contact the manufacturer. You can also report adverse events to the FDA through its MedWatch program. In an emergency, call your local emergency number.

Questions

Questions about a product's regulatory status? Contact our team, call +1 762-214-2594 or email sales@wellnessterritory.com. We are open Monday to Sunday, 9am to 9pm EST.

This page is general information and is not legal or medical advice.