The following data is part of a premarket notification filed by Shenzhen Osto Technology Co., Ltd. with the FDA for Dual Output Digital Therapy Massager.
Device ID | K172834 |
510k Number | K172834 |
Device Name: | Dual Output Digital Therapy Massager |
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 | Cecilia Ceng 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 | 2017-09-19 |
Decision Date | 2018-09-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06950940801165 | K172834 | 000 |
06950940801394 | K172834 | 000 |
06950940801318 | K172834 | 000 |
06950940801608 | K172834 | 000 |
06950940801899 | K172834 | 000 |
06950940801936 | K172834 | 000 |
06950940801967 | K172834 | 000 |
06950940802032 | K172834 | 000 |