Identifiers
- 510(k) Number
- K212342 FDA 510(k)
- FDA Product Code
- NFO 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)
The ZIIP+ Device is a high-quality, FDA-cleared neurostimulator designed for the treatment of various neurological conditions. This device uses transcutaneous electrical stimulation to modulate neural activity, providing effective pain relief and improving quality of life for patients.
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 | K212342 | Class II | Active |
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Manufacturer
- Manufacturer
- Ziip, Inc.
Sources (1)
- FDA 510(k) K212342 24 fields · synced Jul 22, 2026