Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K200727 |
Device Name |
TENS and Muscle Stimulator |
Applicant |
Shenzhen As Tec Technology Co., Ltd |
8E XinBaoYi Industrial Bld, Houting Village, Beiting Road, |
Shajing |
Shenzhen,
CN
518012
|
|
Applicant Contact |
Connie Li |
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 | 03/20/2020 |
Decision Date | 06/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|