K233485
- 510(k) number
- K233485
- Device name
- M-Wave
- Applicant
- Zynex Medical, Inc. CO · US
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2024-01-26
- Date received
- 2023-10-27
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233485
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.