Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K121719 |
Device Name |
SM TENS & PMS |
Applicant |
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
ROOM 1706, NO. 128 SONGLE RD |
SONGJIANG AREA |
SHANGHAI,
CN
201600
|
|
Applicant Contact |
DORIS DONG |
Correspondent |
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
ROOM 1706, NO. 128 SONGLE RD |
SONGJIANG AREA |
SHANGHAI,
CN
201600
|
|
Correspondent Contact |
DORIS DONG |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2012 |
Decision Date | 05/10/2013 |
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
|
|
|