Cleared Traditional

Normatec Go

K221666 · NormaTec Industries, LP · Physical Medicine
Jul 2022
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K221666 is an FDA 510(k) clearance for the Normatec Go, 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 July 14, 2022, 36 days after receiving the submission on June 8, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K221666 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2022
Decision Date July 14, 2022
Days to Decision 36 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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