The following data is part of a premarket notification filed by Biegler Gmbh with the FDA for P-stim.
| Device ID | K140788 |
| 510k Number | K140788 |
| Device Name: | P-STIM |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden BIEGLER GMBH 24301 WOODSAGE DR Bonita Springs, FL 34134 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-06-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() P-STIM 85857182 not registered Dead/Abandoned |
AccelSPINE 2013-02-22 |
![]() P-STIM 79140794 not registered Dead/Abandoned |
Biegler GmbH 2013-07-30 |