Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K161974 |
Device Name |
SLENDERTONE® Connect Abs, Type 570 |
Applicant |
Bio-Medical Research Ltd. |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Applicant Contact |
Anne-Marie Keenan |
Correspondent |
Bio-Medical Research Ltd. |
Parkmore Business Park West |
Galway,
IE
H91 NHT7
|
|
Correspondent Contact |
Anne-Marie Keenan |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/18/2016 |
Decision Date | 11/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|