Medical Device Manufacturer · US , Washington , DC

NormaTec Industries, LP

9 submissions · 9 cleared · Since 2012

Total

Cleared

Denied

NormaTec Industries, LP — FDA 510(k) Submissions

NormaTec Industries, LP has submitted 9 FDA 510(k) premarket notifications since 2012, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Massager, Powered Inflatable Tube, Sleeve, Limb, Compressible . Use the specialty filter in the sidebar to narrow results.

9 devices

1–9 of 9

Normatec Elite Hip

K251905 · IRP Massager, Powered... · Physical Medicine

Sep 2025 90d

Normatec Elite

K240122 · IRP Massager, Powered... · Physical Medicine

Mar 2024 65d

Normatec Go

K221666 · IRP Massager, Powered... · Physical Medicine

Jul 2022 36d

Normatec 3