Guide · Regulatory

What FDA cleared actually means on a recovery device

It means the device was reviewed under a 510(k) submission, given a K-number, and cleared for a specific written indication. It does not mean the FDA endorsed it, tested its benefits, or approved any claim in the marketing. Most recovery devices are not cleared at all — they are sold as general wellness products, which requires no review.

Clearances indexed

Compression cleared

YES

Percussion cleared

Product code

IRP

THE TWO CATEGORIES ON THIS SITE

Compression systems are regulated devices. Normatec 3 is cleared under K220217, Normatec Elite under K240122, Normatec Go under K221666 and Therabody's JetBoots PRO Plus under K241256 — all Class II, all under product code IRP, which is the same regulatory category. That is a genuinely useful fact when choosing between brands: the FDA treats them as equivalent in kind.

Percussion devices are not. No Theragun and no Hypervolt carries a clearance. They are general wellness products, which is a legitimate category — it simply means no regulatory body has reviewed them, and no claim about them has been vetted.

WHAT A CLEARANCE IS NOT

It is not approval. Clearance means substantially equivalent to a device already on the market — the predicate. Approval is a different, much higher bar that these devices do not go through.
It is not evidence of benefit. The 510(k) pathway asks whether the device is equivalent and safe, not whether it works better than doing nothing.
It is not a licence for the marketing copy. The cleared indication is a specific sentence. Anything the brand says beyond it is marketing, not regulation.
It is not permanent proof of anything about a newer model. Clearances attach to specific devices; a new generation may or may not be covered.

HOW TO CHECK ONE YOURSELF

Every clearance is a public record with a number. If a product page says FDA cleared, the K-number should be findable, and the indication for use is written out in the record. When a brand makes the claim and does not publish the number, that is worth noticing — not because the claim is necessarily false, but because a claim you cannot check is not doing the work a clearance is supposed to do.

Worth knowing

The TheraFace Mask page states FDA cleared and gives no K-number. We could not retrieve a matching record to cite, so its product page here says exactly that rather than repeating or dismissing the claim.

WHAT THIS SITE DOES WITH IT

Every product page carries a regulatory block. Where a clearance exists it names the K-number, the class, the product code and the decision date. Where none exists it says so plainly. We never state or imply a claim beyond the cleared indication, and we never use a clearance as a proxy for effectiveness.