TENSWave
FDA 510(k) clearance K241228 · decided 2024-08-27
Clearance details
- K-number
- K241228
- Device name
- TENSWave
- Applicant
- Zynex Medical Officer
- Decision
- Substantially Equivalent
- Date received
- 2024-05-02
- Decision date
- 2024-08-27
- Days to decision
- 117 days
- Clearance type
- Abbreviated
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.