Normatec compression boots: every FDA clearance, and who holds it

Last reviewed August 2026.

Pneumatic compression boots are regulated devices. They clear the FDA under product code IRP — “Massager, Powered Inflatable Tube”, class 2 — and there are 156 clearances on file under it. This page lists the Normatec line against the K-numbers actually on file, pulled from the FDA's own database rather than from anyone's marketing copy.

The thing worth knowing before you spend $800 on a pair: the brand on the box does not hold the clearance. Every Normatec device is cleared under NormaTec Industries, LP, and a 510(k) search for applicant Hyperice returns nothing at all. Hyperice acquired Normatec, and the clearances stayed with the original entity. That is not a red flag — it is the ordinary shape of a device acquisition, and it is the same OEM/licensor-held tier we already apply to iRestore, HairMax and Bosley on the hair page. It only matters because a brand that does not hold its own clearance cannot be checked by searching its own name, which is exactly what most buyers try.

Every Normatec clearance on file

What a clearance here does and does not mean

A 510(k) is a substantial-equivalence review: the FDA agreed the device is as safe and effective as one already on the market. It is not FDA approval, which is a stricter and separate pathway, and it is not evidence that compression speeds your recovery. Product code IRP covers the pump and the sleeve as a massager. We index the record and the claim; we test nothing and give no medical advice.

One practical consequence of the holder mismatch: if you want to verify any of this yourself, search the FDA database for NormaTec, not Hyperice. Each K-number above links straight to its record.

FDA record pulled 2026-08-31. LED masks, claim by claim → · laser caps for hair loss →

LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.

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