Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K190115 |
Device Name |
MHD TENS |
Applicant |
MingHuangDa Electronic Co., Ltd |
Floor6, Building A, Taixinglong Industrial Park |
Hezhou Village, Xixiang Town |
Baoan District, Shenzhen,
CN
518100
|
|
Applicant Contact |
Zhang Guixiang |
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 | 01/24/2019 |
Decision Date | 06/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|