Cleared Traditional

Normatec Elite

K240122 · NormaTec Industries, LP · Physical Medicine
Mar 2024
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K240122 is an FDA 510(k) clearance for the Normatec Elite, 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 March 21, 2024, 65 days after receiving the submission on January 16, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K240122 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2024
Decision Date March 21, 2024
Days to Decision 65 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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