Data / Medical devices / Taiwan / Ya Horng Electronic Co., Ltd.
Ya Horng Electronic Co., Ltd.: FDA-registered device maker in Tainan, Taiwan, 1 510(k) clearance
Ya Horng Electronic Co., Ltd. is registered with the FDA (registration 3001149827) in Tainan, Taiwan. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001149827
- Address
- No.35, Shalun, Anding Dist., Tainan, Taiwan, 745
- Owner or operator
- YAHORNG DONGGUAN ELECTRONIC CO LTD (10050466)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 21, 2017
- Registered through
- 2026
- Brand names listed
- Body Scan, Model:wbs08, INDEX BPM, OR200, SONU, Withings BeamO (SCT02), Withings Scan Monitor 2 (Body Scan, wbs08)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Contract manufacturer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Contract manufacturer | accessdata.fda.gov |
| External Mechanical Stimulator For The Relief Of Congestion | QZC | 2 | Contract manufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| August 30, 2022 | K221486 | INDEX BPM | DXN | Substantially Equivalent | Ya Horng Electronic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Electronic Thermometer
- All makers of Electrocardiograph
- All makers of Stethoscope, Electronic
- All makers of Analyzer, Body Composition, Exempt
- All makers of Toothbrush, Powered
- All makers of External Mechanical Stimulator For The Relief Of Congestion
Updated August 30, 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.