NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM— 510(k) K111279

Name: FDA 510(k) clearance K111279
Creator: U.S. Food and Drug Administration
Published: 2011-09-20

Substantially Equivalent

Zynex Medical, Inc.

FDA 510(k) clearance K111279 for NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM, Substantially Equivalent on 2011-09-20. Applicant: Zynex Medical, Inc.. Device class: 2.

Clearance details

Applicant: Zynex Medical, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2011-05-05
Decision date: 2011-09-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lone Tree, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IPF

view all

K253542 — Apollo Quattro (APQ-10M)2026-06-08
K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)2026-06-02
K260142 — StimelMD (SSMD) system2026-05-27
K251083 — Compact II2025-09-12
K241433 — EVE Synergy (EVE-20M)2025-06-04

More clearances from Zynex Medical, Inc.

view all

K233485 — M-Wave2024-01-26
K223217 — Zynex Monitoring System, Model CM-16002023-06-16
K191697 — Cardiac Monitor 15002020-02-21
K121820 — INWAVE2012-08-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.