The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Health Expert Elctronic Stimulator.
| Device ID | K133929 |
| 510k Number | K133929 |
| Device Name: | HEALTH EXPERT ELCTRONIC STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED N0. 43 LONGFENG ROAD XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT Shenzhen City, Guangdong Province, CN 518116 |
| Contact | Li Yang |
| Correspondent | Li Yang SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED N0. 43 LONGFENG ROAD XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT Shenzhen City, Guangdong Province, CN 518116 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950940802117 | K133929 | 000 |