Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K100320 |
Device Name |
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 |
Applicant |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, WEST |
GALWAY,
IE
|
|
Applicant Contact |
DEIRDRE BARROW |
Correspondent |
BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, WEST |
GALWAY,
IE
|
|
Correspondent Contact |
DEIRDRE BARROW |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 02/04/2010 |
Decision Date | 05/05/2010 |
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
|
|
|