Cleared Traditional

Pulse Rx 2.0, Pulse Pro Rx 2.0

K183328 · NormaTec Industries, LP · Cardiovascular
Dec 2018
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K183328 is an FDA 510(k) clearance for the Pulse Rx 2.0, Pulse Pro Rx 2.0, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on December 21, 2018, 21 days after receiving the submission on November 30, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K183328 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2018
Decision Date December 21, 2018
Days to Decision 21 days
Submission Type Traditional
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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