Why a prescription is required
A hyperbaric chamber raises the pressure around the whole body above normal atmospheric pressure. That makes it a medical device. FDA lists hyperbaric chambers under Product Code CBF and regulation 21 CFR 868.5470 as Class II devices that go through 510(k) premarket review.
FDA 510(k) clearance concerns the device itself: its design, performance, labeling, and manufacturing controls. The prescription requirement sits alongside that clearance. It makes sure a licensed healthcare provider is involved before a person begins using a pressurized device.
Calling a chamber a wellness product does not change this
Some sellers describe full-body chambers as wellness or lifestyle products. A marketing label does not change how FDA classifies a hyperbaric chamber. If you are comparing sellers, ask for the device's 510(k) clearance and confirm it in FDA's device classification database, and ask how the seller handles the prescription requirement.
What the prescription covers, and what it does not
A prescription authorizes a person to obtain and use the device under a clinician's direction. The clinician, not the manufacturer, determines:
- Whether hyperbaric therapy is appropriate for the individual
- The breathing gas and any supplemental oxygen
- The pressure, stated in ATA
- Session length, frequency, and total number of sessions
These variables together make up the dose. Pressure and oxygen concentration are separate variables, and two protocols that share a name can deliver very different exposures. OxyHealth does not prescribe protocols or recommend session counts.
Device clearance and clinical use are different things
FDA clearance applies to a device and its cleared labeling. How a physician uses a cleared device for a particular patient is a separate medical judgment. Research on conditions outside a device's cleared indications does not mean the device is cleared for those uses, and a physician's decision to use a cleared device does not make the device uncleared.
How the process works with OxyHealth
- Speak with a licensed healthcare provider about whether hyperbaric therapy is appropriate for you.
- Contact OxyHealth to discuss chamber types and what documentation is needed.
- Your provider supplies the prescription and determines your protocol.
- Follow the chamber's instructions for use and the training OxyHealth provides.
A prescription does not determine insurance coverage. See the insurance coverage guide for how payers approach hyperbaric therapy.