Cleared Abbreviated

M-Wave

K233485 · Zynex Medical, Inc. · Physical Medicine
Jan 2024
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K233485 is an FDA 510(k) clearance for the M-Wave, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on January 26, 2024, 91 days after receiving the submission on October 27, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K233485 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2023
Decision Date January 26, 2024
Days to Decision 91 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