Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K143430 |
Device Name |
SmartTENS |
Applicant |
EASYMED INSTRUMENT CO., LTD. |
5/F-6/F, BLOCK A, GUPO GONGMAO BLDG |
FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT |
DALIANG, SHUNDE, FOSHAN, GUANG DONG,
CN
528300
|
|
Applicant Contact |
Jeffery Wu(Tingjie Wu) |
Correspondent |
EASYMED INSTRUMENT CO., LTD. |
5/F-6/F, BLOCK A, GUPO GONGMAO BLDG |
FENGXIN ROAD, FENGXIANG INDUSTRIAL DISTRICT |
DALIANG, SHUNDE, FOSHAN, GUANG DONG,
CN
528300
|
|
Correspondent Contact |
Jeffery Wu(Tingjie Wu) |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 12/01/2014 |
Decision Date | 05/29/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|