Data / Medical devices / China / Shenzhen Sinrel Tech Ltd
Shenzhen Sinrel Tech Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Sinrel Tech Ltd is registered with the FDA (registration 3029924973) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3029924973
- Address
- 1st Floor, Building 6, No.27, Yongnan Road,Shajing Street, Baoan District, Shenzhen Guangdong, China, 518103
- Owner or operator
- SHENZHEN SINREL TECH LTD (10089019)
- Roles
- Manufacturer
- First device listed
- October 29, 2023
- Registered through
- 2026
- Brand names listed
- TENS & PMS Unit, YF1503, YF1503X, YF1504, YF1504V, YF1508C, YF1510, YF1511, YF1512, YF1513, TENS XS PRO, YF1505, YF1506, YF1556, OX1503, YF1566, YF1572, YF1581
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2022 | K220005 | TENS & PMS Unit | NUH | Substantially Equivalent | Shenzhen Yuehua Xinsen Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated April 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.