Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K211736 |
Device Name |
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) |
Applicant |
Shenzhen OSTO Technology Company Limited |
No.43 Longfeng Road, Xinsheng Community, Longgang Street |
Longgang District |
Shenzhen,
CN
518116
|
|
Applicant Contact |
Li Yang |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu |
District |
Guangzhou,
CN
510700
|
|
Correspondent Contact |
Cassis Lee |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2021 |
Decision Date | 09/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|