Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K010335 |
FOIA Releasable 510(k) |
K010335
|
Device Name |
SLENDERTONE FLEX, MODEL, 512 |
Applicant |
BIO-MEDICAL RESEARCH, LTD. |
700 13TH ST. NW |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
ROBERT DORMER |
Correspondent |
BIO-MEDICAL RESEARCH, LTD. |
700 13TH ST. NW |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
ROBERT DORMER |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 02/02/2001 |
Decision Date | 09/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|