Cleared Traditional

Normatec Elite Hip

K251905 · NormaTec Industries, LP · Physical Medicine
Sep 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251905 is an FDA 510(k) clearance for the Normatec Elite Hip, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on September 18, 2025, 90 days after receiving the submission on June 20, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K251905 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2025
Decision Date September 18, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IRP — Massager, Powered Inflatable Tube
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5650

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