Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K030708 |
Device Name |
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 |
Applicant |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, |
WEST GALWAY,
IE
|
|
Applicant Contact |
MICHELLE SAWYER |
Correspondent |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, |
WEST GALWAY,
IE
|
|
Correspondent Contact |
MICHELLE SAWYER |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 03/06/2003 |
Decision Date | 06/25/2003 |
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
|
|
|