Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K061914 |
Device Name |
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS |
Applicant |
SPORT-ELEC S.A. |
ROUTE DE POUEN BP 35 |
BOURGTHEROULDE INFREVILLE,
FR
91400
|
|
Applicant Contact |
ARMELLE LAPRELLE |
Correspondent |
SPORT-ELEC S.A. |
ROUTE DE POUEN BP 35 |
BOURGTHEROULDE INFREVILLE,
FR
91400
|
|
Correspondent Contact |
ARMELLE LAPRELLE |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/06/2006 |
Decision Date | 07/26/2007 |
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
|
|
|