Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K143551 |
Device Name |
Compex Wireless USA |
Applicant |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Applicant Contact |
GINA FLORES |
Correspondent |
DJO, LLC |
1430 DECISION STREET |
VISTA,
CA
92081 -8553
|
|
Correspondent Contact |
GINA FLORES |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 12/15/2014 |
Decision Date | 04/28/2015 |
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
|
|
|