Question 1

What types of medical devices does Ya Horng Electronic Co., Ltd. manufacture?

Accepted Answer

Ya Horng Electronic Co., Ltd. specializes in portable electronic medical devices. Their primary products include automatic-inflation electronic sphygmomanometers (blood pressure monitors) for arm or wrist use, as well as intermittent electronic patient thermometers. These devices are designed for both home and clinical settings to measure blood pressure and temperature efficiently.

Question 2

Where is Ya Horng Electronic Co., Ltd. based?

Accepted Answer

Ya Horng Electronic Co., Ltd. is headquartered in the United States. The company’s location in the U.S. ensures compliance with U.S. regulatory standards for the devices it manufactures, including those listed in the FDA’s databases.

Question 3

Which regulatory registries list Ya Horng Electronic Co., Ltd.’s devices?

Accepted Answer

Ya Horng Electronic Co., Ltd.’s devices are listed in the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track Class II devices, which include their blood pressure monitors, ensuring transparency in their regulatory status.

Question 4

How are Ya Horng Electronic Co., Ltd.’s devices classified under U.S. regulations?

Accepted Answer

Ya Horng Electronic Co., Ltd.’s blood pressure monitors fall under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as automatic-inflation electronic sphygmomanometers. Classification helps determine the regulatory pathway and oversight required for these products.

Device	Model / Reference	Registries	Class	Status
Nokia	BP-801	FDA UDI	Class II	Active
Withings	SCT01	FDA UDI	Class II	Active
Nokia	BP-801	FDA UDI	Class II	Active
Garmin	BP707	FDA UDI	Class II	Active
Withings	BP-801	FDA UDI	Class II	Active
Nokia	SCT01	FDA UDI	Class II	Active
Withings	BP-801	FDA UDI	Class II	Active
Withings	BP-801 (B-Grade)	FDA UDI	Class II	Active
Pc Compatible Blood Pressure Monitor, Model Ak-4000tu, Bp-410u, Bp-410r; Automatic Digital Wrist Blood Press. Monitor.	K051862	FDA 510(k)	Class II	Active
Amluck Ya Horng Pc Compatible Wrist Blood Pressure Monitor, Model Ak-4000t	K040528	FDA 510(k)	Class II	Active
Amluck, Ya Horng	K051863	FDA 510(k)	Class II	Active
Ya Horng Arm Type Digital Blood Pressure Monitor, Models Bp-600, Bp-600r, Bp-600u, Bp-600b, Bp-600rb, Bp-600ub, Bp-600j	K081590	FDA 510(k)	Class II	Active
Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-100j, Bp-110j; Digital Wrist Blood Pressure Monitor, Bp-500, Bp-500	K072860	FDA 510(k)	Class II	Active
Ya Horng Blood Pressure Monitor, Ya Horng Blood Pressure Monitor, Bluetooth Transmission	K121025	FDA 510(k)	Class II	Active
Tricot Blood Pressure Cuff	K051539	FDA 510(k)	Class II	Active
Amluck, Ya Horng	K042581	FDA 510(k)	Class II	Active
Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-700, Bp-700t, Bp700u, Bp-700b, Bp-700tb, Bp-700ub, Bp-700tub	K090058	FDA 510(k)	Class II	Active
Index Bpm	K221486	FDA 510(k)	Class II	Active

Ya Horng Electronic Co., Ltd.

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