Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K071666 |
Device Name |
SLENDERTONE ENERVIVE, MODEL 561 |
Applicant |
BIO-MEDICAL RESEARCH CORP. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
|
|
Applicant Contact |
ANNE-MARIE KEENAN |
Correspondent |
BIO-MEDICAL RESEARCH CORP. |
PARKMORE BUSINESS PARK WEST |
GALWAY,
IE
|
|
Correspondent Contact |
ANNE-MARIE KEENAN |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 06/18/2007 |
Decision Date | 03/12/2008 |
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
|
|
|