Joytech Healthcare Co. , Ltd. · Class II · Cleared Feb 13, 2026
| K-number | K252685 |
| Device name | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) |
| Applicant | Joytech Healthcare Co. , Ltd. |
| Product code | DXN |
| Device class | Class II |
| Decision date | Feb 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1130 |
Arm-type fully automatic digital blood pressure monitors that measure systolic and diastolic blood pressure and pulse rate in adults and adolescents over 12 years with arm circumference 22-42 cm. Some models (with -P designation) are also indicated for use in pregnant women with normotension, gestational hypertension, or preeclampsia. Devices use oscillometric measurement with automatic cuff inflation/deflation and can include features like Bluetooth, WiFi, irregular heartbeat detection, and memory storage.
Subject devices use the same oscillometric measuring principle and upper-arm application site as predicate devices. Minor differences include varying wireless capabilities (Bluetooth/WiFi on some models), different power sources (lithium batteries vs AAA batteries), different memory capacity (2×150 vs 500 memories), and slightly different measurement ranges. All share identical accuracy specifications (±3 mmHg pressure, ±5% pulse), irregular heartbeat detection, and cuff loose indicators.
IEC 60601-1:2005+AMD, AAMI ES60601-1:2005+AMD, IEC 80601-2-30:2018, IEC 60601-1-11:2015+AMD, IEC 60601-1-2:2014+AMD, ISO 10993 series (biocompatibility), ISO 81060-2:2018+AMD (clinical validation), FCC Part 15 Subpart C, and ANSI C63.27-2021 (wireless coexistence).
Subject devices share identical measuring principle, method, and intended home-use purpose as predicate TMB-2092-G (K232621). Differences in wireless modules, battery types, and memory capacity do not raise different safety/effectiveness questions as they are supported by bench testing equivalence and previous clinical data from DBP-6279B. New clinical study (115 pregnant subjects) validates accuracy in pregnant population per ISO 81060-2, while general population coverage leverages prior clinical data from K230566 with 95 subjects.
View the full FDA submission: accessdata.fda.gov