Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K220283 |
Device Name |
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) |
Applicant |
Hong Qiangxing (Shen Zhen) Electronics Limited |
4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road |
Baoan 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 | 02/01/2022 |
Decision Date | 05/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|