The following data is part of a premarket notification filed by Biegler Gmbh with the FDA for Stivax.
| Device ID | K152571 |
| 510k Number | K152571 |
| Device Name: | Stivax |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | BIEGLER GMBH ALLHANGSTRASSE 18A Mauerbach, AT 3001 |
| Contact | Friedrich Netauschek |
| Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DRIVE 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 | 2015-09-09 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STIVAX 79127159 4438117 Live/Registered |
Biegler GmbH 2013-02-21 |