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 |