Device Classification Name |
media, electroconductive
|
510(k) Number |
K200402 |
Device Name |
DR-HO'S Electro Therapy Conductive Gel |
Applicant |
Guangzhou Xinbo Electronic Co., Ltd. |
23 Building, Phase-II, Huachuang Industry Park, Panyu, |
Guangzhou,China. |
Guangzhou,
CN
511450
|
|
Applicant Contact |
Sammy Li |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, |
Huangpu District |
Guangzhou,
CN
510700
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 02/19/2020 |
Decision Date | 11/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|