The following data is part of a premarket notification filed by Shenzhen Osto Technology Co., Ltd. with the FDA for Neck Care Therapy, Model: Syk 509b.
Device ID | K172897 |
510k Number | K172897 |
Device Name: | Neck Care Therapy, Model: SYK 509B |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Shenzhen OSTO Technology Co., Ltd. No.43 Longfeng Road, Xinsheng Community Longgang Street Longgang District Shenzhen, CN |
Contact | Li Yang |
Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510006 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-22 |
Decision Date | 2018-12-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06950940801448 | K172897 | 000 |
06950940801462 | K172897 | 000 |
06950940801639 | K172897 | 000 |