Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K172897 |
Device Name |
Neck Care Therapy, Model: SYK 509B |
Applicant |
Shenzhen OSTO Technology Co., Ltd. |
No.43 Longfeng Road, Xinsheng Community |
Longgang Street Longgang District |
Shenzhen,
CN
|
|
Applicant Contact |
Li Yang |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
Suite 306, Kecheng Mansion, No.121 Science Road |
Guangzhou Science Park |
Guangzhou,
CN
510006
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/22/2017 |
Decision Date | 12/07/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|