K241228
- 510(k) number
- K241228
- Device name
- TENSWave
- Applicant
- Zynex Medical Officer CO · US
- Product code
- GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
- Decision date
- 2024-08-27
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.