ZIIP+ Device
by Ziip, Inc.
510(k) K212342
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212342 | Date23 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K212342
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NFO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212342
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ZIIP Beauty Blush HALO | Blush HALO | 00851367006156 | — | On the market |
| ZIIP Beauty DOT - Grey | DOT - Grey | 00851367006194 | — | On the market |
| ZIIP Beauty DOT - Purple | DOT - Purple | 00851367006163 | — | On the market |
| ZIIP Beauty DOT - White | DOT - White | 00851367006187 | — | On the market |
| ZIIP Beauty DOT - Yellow | DOT - Yellow | 00851367006170 | — | On the market |
| ZIIP Beauty EYES | EYES | 00851367006224 | — | No longer on the market |
| ZIIP Beauty HALO | HALO | 00851367006149 | — | On the market |
| ZIIP Beauty HALO - CN | HALO - CN | 00851367006200 | — | On the market |
| ZIIP Beauty LIPS | LIPS | 00851367006217 | — | On the market |
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Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).
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