The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Ansistim-pp.
| Device ID | K220397 |
| 510k Number | K220397 |
| Device Name: | ANSiStim-PP |
| Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Applicant | DyAnsys, Inc. 300, North Bayshore Boulevard San Mateo, CA 94401 |
| Contact | Srini Nageshwar |
| Correspondent | Srini Nageshwar DyAnsys, Inc. 300, North Bayshore Boulevard San Mateo, CA 94401 |
| Product Code | NHI |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-05-12 |