Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K163165 |
Device Name |
AM-100 |
Applicant |
BTL INDUSTRIES, INC |
47 Loring Drive |
Framington,
MA
01702
|
|
Applicant Contact |
David Chmel |
Correspondent |
BTL INDUSTRIES, INC |
47 Loring Drive |
Framington,
MA
01702
|
|
Correspondent Contact |
David Chmel |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 11/10/2016 |
Decision Date | 02/16/2017 |
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
|
|
|