The following data is part of a premarket notification filed by Dyansys Inc with the FDA for Ansistim-pp.
| Device ID | K170391 |
| 510k Number | K170391 |
| Device Name: | ANSiStim-PP |
| Classification | Stimulator, Electro-acupuncture |
| 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 | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-08 |
| Decision Date | 2017-03-09 |
| Summary: | summary |