Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K143207 |
Device Name |
Revitive IX (OTC) |
Applicant |
Actegy, Ltd |
8 Queen Square, Ascot Business Park |
Lyndhurst Road |
Ascot,
GB
Sl5 9FE
|
|
Applicant Contact |
Angela Glover |
Correspondent |
Hogan Lovells US LLP |
Columbia square 555 13th Street, NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/07/2014 |
Decision Date | 03/23/2015 |
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
|
|
|