Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K133965 |
Device Name |
OTC EMS STIMULATOR |
Applicant |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
No. 3 Building XiliBaimang Xusheng Industrial Estate |
Nanshan |
SHENZHEN,
CN
518108
|
|
Applicant Contact |
QILIAN LIU |
Correspondent |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
No. 3 Building XiliBaimang Xusheng Industrial Estate |
Nanshan |
SHENZHEN,
CN
518108
|
|
Correspondent Contact |
QILIAN LIU |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 12/24/2013 |
Decision Date | 06/16/2014 |
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
|
|
|