Ya Horng Electronic Co., Ltd.
Tainan, TW
Ya Horng Electronic Co., Ltd. appears in FDA device records in Tainan, TW. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Ya Horng Electronic Co., Ltd. between 2004 and 2022. The busiest year on record is 2005, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2005 | 3 |
| 2008 | 2 |
| 2009 | 1 |
| 2012 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221486 | INDEX BPM | DXN | Substantially Equivalent | |
| K121025 | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION | DXN | Substantially Equivalent | |
| K090058 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB | DXN | Substantially Equivalent | |
| K081590 | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J | DXN | Substantially Equivalent | |
| K072860 | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 | DXN | Substantially Equivalent | |
| K051862 | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. | DXN | Substantially Equivalent | |
| K051863 | AMLUCK, YA HORNG | DXN | Substantially Equivalent | |
| K051539 | TRICOT BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | |
| K042581 | AMLUCK, YA HORNG | DXN | Substantially Equivalent | |
| K040528 | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001149827 | 3001149827 | Ya Horng Electronic Co., Ltd. | No.35, Shalun, Anding Dist.,, Tainan 745 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PUHAnalyzer, Body Composition, Exempt
- DXQBlood Pressure Cuff
- SDVClinical Electronic Thermometer
- DPSElectrocardiograph
- QZCExternal Mechanical Stimulator For The Relief Of Congestion
- DQDStethoscope, Electronic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JEQToothbrush, Powered
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain