Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K140168 |
Device Name |
EASYSTIM TN28_OTC |
Applicant |
EASYMED INSTRUMENTS CO., LTD. |
5/F- 6/F, Block A, Gupo Gongmao Building |
Fengxin Road, Fengxiang Industrial District |
Daliang, Shunde, Foshan,
CN
528300
|
|
Applicant Contact |
JEFFERY WU |
Correspondent |
EASYMED INSTRUMENTS CO., LTD. |
5/F- 6/F, Block A, Gupo Gongmao Building |
Fengxin Road, Fengxiang Industrial District |
Daliang, Shunde, Foshan,
CN
528300
|
|
Correspondent Contact |
JEFFERY WU |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 01/23/2014 |
Decision Date | 08/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|