Cleared Special

PlasmaWave

K211253 · Manamed, Inc. · Cardiovascular
May 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K211253 is an FDA 510(k) clearance for the PlasmaWave, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on May 26, 2021, 30 days after receiving the submission on April 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K211253 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2021
Decision Date May 26, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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