Device Classification Name |
Stimulator, Electro-Acupuncture
|
510(k) Number |
K152571 |
Device Name |
Stivax |
Applicant |
BIEGLER GMBH |
ALLHANGSTRASSE 18A |
MAUERBACH,
AT
3001
|
|
Applicant Contact |
FRIEDRICH NETAUSCHEK |
Correspondent |
PROMEDIC, INC. |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Classification Product Code |
|
Date Received | 09/09/2015 |
Decision Date | 05/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|