Cleared Traditional

PlasmaFlight

K200351 · Manamed, Inc. · Physical Medicine
Aug 2020
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K200351 is an FDA 510(k) clearance for the PlasmaFlight, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on August 5, 2020, 175 days after receiving the submission on February 12, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K200351 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2020
Decision Date August 05, 2020
Days to Decision 175 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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