Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K130074 |
Device Name |
GYMFORM ABS-A-ROUND |
Applicant |
WELL BRAIN INTERNATIONAL, LTD. |
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD |
HONG KONG,
CN
999077
|
|
Applicant Contact |
VICTOR K WAI |
Correspondent |
WELL BRAIN INTERNATIONAL, LTD. |
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD |
HONG KONG,
CN
999077
|
|
Correspondent Contact |
VICTOR K WAI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 01/14/2013 |
Decision Date | 08/15/2013 |
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
|
|
|