Cleared Abbreviated

K111279 - NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (FDA 510(k) Clearance)

K111279 · Zynex Medical, Inc. · Physical Medicine device

Sep 2011

Decision

138d

Days

Class 2

Risk

K111279 is an FDA 510(k) clearance for the NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K111279 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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