Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K200382 |
Device Name |
BTL-703-2 |
Applicant |
BTL |
362 Elm Street |
Marlborough,
MA
01752
|
|
Applicant Contact |
David Chmel |
Correspondent |
BTL |
362 Elm Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
David Chmel |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 01/06/2021 |
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
|
|
|