K170391 is an FDA 510(k) clearance for the ANSiStim-PP. This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on March 9, 2017, 29 days after receiving the submission on February 8, 2017.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K170391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2017 |
| Decision Date | March 09, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | BWK - Stimulator, Electro-acupuncture |
| Device Class | - |