K140788 is an FDA 510(k) clearance for the P-STIM. This device is classified as a Stimulator, Electro-acupuncture.
Submitted by Biegler GmbH (Bonita Springs, US). The FDA issued a Cleared decision on June 27, 2014, 88 days after receiving the submission on March 31, 2014.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K140788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2014 |
| Decision Date | June 27, 2014 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | BWK — Stimulator, Electro-acupuncture |
| Device Class | — |