Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K190009 |
Device Name |
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
Applicant |
Hong Qiangxing (Shen Zhen) Electronics Limited |
4F, Jingcheng Building, Xicheng Industrial Zone, |
Xixiang Road, Bao'an District |
Shenzhen,
CN
518126
|
|
Applicant Contact |
Xu Jianhua |
Correspondent |
Shanghai CV Technology Co., Ltd. |
Room 903, No. 19 Dongbao Road, Songjiang Area |
Shanghai,
CN
201613
|
|
Correspondent Contact |
Doris Dong |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2019 |
Decision Date | 12/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|