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 |