Cleared Abbreviated

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM

K111279 · Zynex Medical, Inc. · Physical Medicine
Sep 2011
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K111279 is an FDA 510(k) clearance for the NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Zynex Medical, Inc. (Lone Tree, US). The FDA issued a Cleared decision on September 20, 2011, 138 days after receiving the submission on May 5, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K111279 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2011
Decision Date September 20, 2011
Days to Decision 138 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850