Joytech Healthcare Co. , Ltd. · Class II · Cleared Apr 28, 2026
| K-number | K252501 |
| Device name | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) |
| Applicant | Joytech Healthcare Co. , Ltd. |
| Product code | DXN |
| Device class | Class II |
| Decision date | Apr 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
The Arm-type Fully Automatic Digital Blood Pressure Monitor is a noninvasive, automatic device that measures systolic and diastolic blood pressure and pulse rate using the oscillometric method. It is intended for over-the-counter home and clinical use by adults and adolescents over 12 years of age with arm circumferences ranging from 22–36 cm, 22–42 cm, or 32–48 cm. Some models include optional features such as Bluetooth connectivity, trend charts, 4G messaging, and irregular heartbeat detection.
The subject devices use the same oscillometric measuring principle and upper-arm cuff location as the predicate DBP-6279B. Both measure pressure range 0–299 mmHg with accuracy of ±3 mmHg, and pulse rate 30–180 bpm with ±5% accuracy. Subject devices share identical specifications for inflation (air pump), deflation (solenoid valve), operating conditions, and major functions. Differences include optional Bluetooth/4G wireless transmission and trend chart display in some models, but these do not affect the core blood pressure measurement function.
Electrical safety: IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 80601-2-30:2018, IEC 60601-1-11:2015+AMD1:2020. Electromagnetic compatibility: IEC 60601-1-2:2014+AMD1:2020. Biocompatibility: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021. Wireless/FCC: FCC Part 15 Subpart C, ANSI C63.18-2014, ANSI C63.27-2021. Clinical validation: ISO 81060-2:2018+AMD2020.
The subject devices are substantially equivalent to predicate DBP-6279B because they share identical measuring principle (oscillometric), measurement type (during inflation), cuff location (upper arm), and core specifications including pressure/pulse measurement ranges and accuracy. All major functions (blood pressure, pulse rate, irregular heartbeat detection, memory, WHO classification, low battery detection) are identical. Minor differences in optional wireless features (Bluetooth/4G) and trend charts do not raise new safety or effectiveness issues, as demonstrated by compliance with all applicable electrical safety, EMC, and biocompatibility standards, plus clinical validation per ISO 81060-2.
View the full FDA submission: accessdata.fda.gov