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Tensmate Empimodel 9980
FDA 510(k)Class II (US FDA 510(k))
510(k) K802507
by Empi
Identifiers
- 510(k) Number
- K802507 FDA 510(k)
- FDA Product Code
- GZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
For patients experiencing chronic pain, the TENSMATE EMPIMODEL 9980 is a reliable and effective device for delivering targeted electrical impulses to manage pain relief. Developed with input from Neurology advisory committees and reviewed by experts in the field, this stimulator is designed to provide long-term pain relief through its adjustable pulse width and intensity settings.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K802507 | Class II | Active |
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Manufacturer
- Manufacturer
- Empi
Sources (1)
- FDA 510(k) K802507 24 fields · synced Jul 25, 2026