Guide · Regulatory

FDA Registered vs FDA Cleared: the difference on these product pages

Six Therabody products carry an FDA Registered badge. Registration is a facility listing — a filing that involves no review of the device. None of them, and none of the three products claiming FDA Cleared, publishes a K-number. Hyperice makes no FDA claim at all on its uncleared products.

Say registered

Say cleared

K-numbers given

Hyperice claims

THE TWO THINGS ARE NOT RELATED

Registration means a company has listed itself and its device with the FDA. It is an administrative filing. The FDA does not evaluate the device, does not assess whether it works, and does not assess whether it is safe. Registration is not an approval, a clearance, or an endorsement, and the FDA says so directly.

Clearance means a 510(k) submission was reviewed and the agency issued a K-number, which is a public record anyone can look up, attached to a specific written indication for use.

WHAT WE FOUND ACROSS THE TWO CATALOGUES

Six Therabody products state FDA Registered: RecoveryTherm Cube, RecoveryTherm Knee, ThermBack LED, CryoTherm Palm, TheraCup and WaveDuo.
Three Therabody products state FDA Cleared: TheraFace Mask, TheraFace Mask Glo and TheraFace PRO.
Not one of those nine pages publishes a K-number.
Therabody's compression products are genuinely cleared — JetBoots PRO Plus under K241256 — and that clearance is real and checkable.
Hyperice makes no FDA statement whatsoever on any uncleared product. Its Normatec systems carry real K-numbers: K220217, K240122, K221666.

Worth knowing

That last contrast is the honest heart of this. Hyperice's approach — publish a K-number where one exists, say nothing where one does not — leaves a buyer with less to misread than a badge whose meaning most people will get wrong.

WHY A BADGE WITHOUT A NUMBER MATTERS

A clearance you can look up is a clearance you can check. You can read the indication for use, see the decision date, and see what predicate device it was compared against. A claim with no number attached asks you to take the manufacturer's word for a regulatory status, which is precisely the situation regulatory records exist to prevent.

We are not saying any of these claims is false. TheraFace products may well hold clearances. What we are saying is that on the page where you decide to spend $649.99, the number that would let you verify it is absent — and that a reasonable buyer reading FDA Registered will almost certainly believe it means something closer to FDA Cleared than it does.

HOW TO READ THESE PAGES

FDA Cleared with a K-number — a real clearance you can verify. Read the indication, not the marketing.
FDA Cleared with no K-number — a claim you cannot check. Worth asking support for the number.
FDA Registered — a filing. It tells you nothing about the device itself.
No FDA language at all — a general wellness product, which is a legitimate and honest category.

WHAT THIS SITE DOES

Every product page carries a regulatory block, and its heading changes to match what is actually true: What it is cleared for where a K-number exists, Registered, not cleared where the page claims registration, The clearance claim where clearance is asserted without a number, and What it is not cleared for where no claim is made. We never treat a clearance as evidence a device works, and we never state a claim beyond a cleared indication.