# K111279: Nexwave Combo Muscle Stimulator System

- Pathway: 510(k) (Abbreviated)
- Applicant: Zynex Medical, Inc.
- Decided: Sep 20, 2011 after 138 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Interferential Mode (IFC) Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Neuromuscular Electrical Stimulation Mode (NMES) Muscle Re-education Prevention or Retardation of Disuse Atrophy Increasing Local Blood Circulation Maintaining or Increasing Range of Motion Relaxation of Muscle Spasms Transcutaneous Electrical Nerve Stimulation Mode (TENS) Management and Symptomatic Relief of Chronic Intractable Pain, Post-traumatic and Post-surgical Pain.

Source page: https://510kreport.com/device/K111279
Methodology: https://510kreport.com/methodology