Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K151834 |
Device Name |
BEMER Classic Set, BEMER Pro-Set |
Applicant |
BEMER Int. AG |
Austrasse 15 |
Triesen,
LI
9495
|
|
Applicant Contact |
Sven Bieler |
Correspondent |
Biomaterialize |
P.O. BOX 50 |
Tecumseh,
MI
49286
|
|
Correspondent Contact |
Sven Bieler |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/06/2015 |
Decision Date | 02/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|