Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K210174 |
Device Name |
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set |
Applicant |
Bemer INT. AG |
Austrasse 15 |
Triesen,
LI
9495
|
|
Applicant Contact |
Sandra Schwarzenberger |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 01/22/2021 |
Decision Date | 02/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|