Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K011880 |
Device Name |
COMPEX SPORT |
Applicant |
COMPEX S.A. |
1225 EYE STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
ANSIS M HELMANIS |
Correspondent |
COMPEX S.A. |
1225 EYE STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
ANSIS M HELMANIS |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 06/15/2001 |
Decision Date | 04/17/2002 |
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
|
|
|