The following data is part of a premarket notification filed by Ziip, Inc with the FDA for Ziip+ Device.
| Device ID | K212342 |
| 510k Number | K212342 |
| Device Name: | ZIIP+ Device |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | ZIIP, Inc 1425 Leimert Blvd, Suite 202 Oakland, CA 94062 |
| Contact | David Mason |
| Correspondent | Heather Tanner Hill Regulatory Consulting, LLC 1910 15th Ave E Seattle, WA 98112 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-28 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851367006156 | K212342 | 000 |
| 00851367006149 | K212342 | 000 |