FDA device listing
16-1991 Arm Digital BPM-Standard Adult Size DBP-61E2,16-1993XL Arm Digital BPM XL Adult Size DBP-61E2,16-1994CF…
FDA device listing 1121768672 · JOYTECH HEALTHCARE CO. LTD.
Key facts
| Proprietary names | 16-1991 Arm Digital BPM-Standard Adult Size DBP-61E2,16-1993XL Arm Digital BPM XL Adult Size DBP-61E2,16-1994CF Replacement Cuff-Standard Adult Size,16-1994CF-XL Replacement Cuff-XL Adult Size,211-2112B R.P.M. PRO Blood Pressure Monitor,Arm-type Fully Automatic Digital BloodPressure Monitor,Blood pressure monitor BU 720,Blood pressure monitor DBP-6186,Blood pressure monitor DBP-6186 Plus,Volueth… |
|---|---|
| Owner/operator | JOYTECH HEALTHCARE CO. LTD. |
| Owner/operator number | 10054061 |
| Premarket submissions | K250548 |
| Product codes | DXN |
| Device names | DXN - System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130 |
| Review panels | Cardiovascular |
| Registered establishments | JOYTECH HEALTHCARE CO., LTD., JOYTECH HEALTHCARE CO.,LTD., RENS MEDCARE (CAMBODIA) CO.,LTD. |
| Establishment registrations | 3013053058, 3024790242, 3030671608 |
| FEI numbers | 3013053058, 3024790242, 3030671608 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database