FDA.report

510(k) K250161

Device
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
510(k) number
K250161
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-02
Date received
2025-01-21
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jack Wang
Address
Rm. 301&4f, Block A, Bldg. A, Jingfa Intelligent Manufac Cturing Park Xiaweiyuan, Gushu Community, Xixiang St., Shenzhen CN 518126 518126

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DXN

510(k)DeviceApplicantDecision date
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.2026-05-14
K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06
K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.2026-04-28
K252501Arm-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)Joytech Healthcare Co. , Ltd.2026-04-28
K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.2026-04-21
K260276Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S ProShenzhen AOJ Medical Technology Co., Ltd.2026-04-01
K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)Shenzhen HanHan Technology Co., Ltd.2026-04-01
K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)Shenzhen Urion Technology Co., Ltd.2026-03-26
K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-03-05
K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-23
K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd.2026-02-13
K252685Arm-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)Joytech Healthcare Co. , Ltd.2026-02-13
K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-02-13
K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12
K253142Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)Ningbo Ranor Medical Technology Co., Ltd.2026-01-09