Regulatory Status Explained

Short answer: Hyperbaric chambers, red light devices, cold plunges and cryotherapy equipment are regulated very differently. Some chambers are medical devices that require a prescription, while many red light and cold plunge products are sold for general wellness. This page explains how we describe each, and why we do not make medical claims. It is not legal or medical advice.

Last reviewed: September 2026. Have this page reviewed by qualified regulatory counsel before publishing.

Hyperbaric chambers

• The FDA clears hyperbaric chambers for a specific list of medical conditions, such as decompression sickness, carbon monoxide poisoning and certain non-healing wounds. Treatment for those conditions is delivered under medical supervision at higher pressures.
• Using a chamber for other purposes falls outside those clearances, and the FDA has cautioned consumers about unproven claims.
• Per the manufacturer, Summit to Sea chambers are Class II devices, and a prescription is required to purchase one, except for health clinics.
• Per the manufacturer, Newtowne chambers are FDA cleared under 510(k) K051759 and a prescription is required to purchase them.
• Macy-Pan lists ISO and CE standards for its soft-shell chambers.
• For OxyRevo, Oxyair and Titan, check each listing and ask the manufacturer for its regulatory status and prescription requirement.

See mild vs. medical HBOT.

Red light therapy devices

• Our listings describe most red light devices as intended for general wellness use, following the manufacturer's instructions, and not intended to diagnose, treat, cure or prevent any disease or medical condition.
• Some light-based products are marketed for specific medical purposes elsewhere. We do not make those claims.
• Ask the manufacturer for its regulatory status if you need it for your situation.

PEMF products

PEMF mats and applicators vary in how they are classified and labeled. Read each listing, and ask your doctor and the maker before use if you have an implant such as a pacemaker.

Cold plunges

Cold plunge tubs and chillers are consumer wellness and recreation equipment. Electrical safety matters: chillers and pumps should be properly grounded and GFCI protected.

Cryotherapy equipment

The FDA has warned that whole-body cryotherapy lacks evidence for treating medical conditions. The chambers and devices we list are generally aimed at professional use. Ask each manufacturer about its labeling, training requirements and safety systems.

How we word claims

• We describe what a product is and its specifications, as stated by the manufacturer.
• We do not say a product diagnoses, treats, cures or prevents any disease.
• Where evidence is mixed or early, we say so.
• We link to a doctor-first warning on every health-related guide. See our disclaimer.

What you should do

1. Talk to your physician before buying or using any of these products.
2. Read the manufacturer's manual and labeling.
3. Ask us if you need help finding a manufacturer's regulatory information. Contact our team.