Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K210756 |
Device Name |
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H |
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
510663
|
|
Correspondent Contact |
Li Yang |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2021 |
Decision Date | 06/11/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|