# K233485: M-Wave

- Pathway: 510(k) (Abbreviated)
- Applicant: Zynex Medical, Inc.
- Decided: Jan 26, 2024 after 91 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
This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.

Source page: https://510kreport.com/device/K233485
Methodology: https://510kreport.com/methodology