Research
What FDA cleared means, and what it does not
FDA clearance is a regulatory pathway in which a device maker shows a device is substantially equivalent to a device already on the market for the same use. It is a comparison to something existing, not a finding that the device works for any particular person.
Our device is FDA cleared as a biofeedback device indicated for relaxation training and muscle reeducation. That sentence is the whole of what the clearance supports.
How is clearance different from approval?
They are two different regulatory routes with different evidence requirements. Clearance rests on substantial equivalence to a device already legally marketed. Approval, the stricter route, requires the maker to submit evidence of safety and effectiveness for the stated use.
This is why the phrase "FDA approved" is the wrong phrase for a biofeedback device of this kind. Writing "FDA approved" about a cleared device overstates the regulatory record, and it is one of the most common errors in this category.
| Route | What the maker must show | What it tells a buyer |
|---|---|---|
| Clearance | Substantial equivalence to a legally marketed device for the same use | The device is allowed on the market for a stated indication |
| Approval | Evidence of safety and effectiveness for the stated use | A regulator reviewed effectiveness evidence for that use |
What exactly is our device cleared for?
Relaxation training and muscle reeducation. That is the indication, written the way the clearance is written.
Notice what the indication does not mention. It names no health condition. So no clearance in this category can be used to support a claim about a condition, and we do not make one.
Does clearance mean the device is safe?
Clearance means the device was found substantially equivalent to a predecessor device for the same use, which includes a safety comparison. It is not a personal promise and it is not a statement about you.
Practical safety in a session comes from screening, consent, and a provider willing to stop. We describe our own screening on the standards page rather than leaning on the clearance to do that work.
Why do so many providers get this wrong?
Because approval sounds stronger and shorter, and because the distinction is genuinely unfamiliar outside of regulatory work. Some of the misuse is careless rather than dishonest.
Either way, the effect on a buyer is the same. It implies a level of regulatory review that was never performed for this device category.
How should you use this when comparing providers?
Ask each provider to state the indication in the manufacturer's words. A provider who can do that from memory has read the paperwork. A provider who reaches for approval language has not, or is hoping you will not notice.
The provider questions page turns this into something you can work through in one conversation.
Questions people ask about this
Please read this
Momentous Neurofeedback is a wellness practice. We use an FDA-cleared biofeedback device indicated for relaxation training and muscle reeducation.
We do not provide medical care and we do not assess or identify health conditions. We make no promise about any outcome, and nothing on this site should be read as one.
Sessions are not a substitute for care from a licensed clinician. If you have a health concern, speak with your own provider. In an emergency, call your local emergency number.
Read the indication for yourself
Bring this page to a consultation and ask to see the manufacturer's indication for use in writing.