Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009551875

FEI Number

3009551875

Entity Name

Shenzhen AOJ Medical Technology Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 301&4-5F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Baoan District, Shenzhen Guangdong 518126, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen AOJ Medical Technology Co., Ltd. (Owner Number: 10059056)

Owner / Operator Contact Address

Room 301&4-5F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, Shenzhen, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250470

PMA Number

N/A

All Registered Proprietary Names

Smart Body Scale(4G), Model: SCL-80B Digital Scale, Model: SCL-80A BU 518,ARM-30U,ARM-3030,ARM-30Y,BU 520,ARM-3120,ARM-3020,ARM-3021, ARM-3022,ARM-3023,ARM-3080 Arm Blood Pressure Monitor, ARM-30G+, ARM-30M,ARM-30S,ARM-30T,ARM-HA101, BU 550 ARM-30A+,ARM-30G2, ARM-30Q,ARM-30E+,ARM-3010,ARM-3011,ARM-3012,ARM-3013,ARM-3110, ARM-3040,ARM-30V,ARM-30W,SBM 15 PRESSURE XS PRO, PRESSURE 9S PRO, XS Pro, 9S Pro Arm Blood Pressure Monitor, ARM-30H, ARM-30J, ARM-30K, ARM-90B, BU 750 connect,BU 800 Infrared Thermometer, TM 740 connect, FTM-D1 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 Blood Pressure Monitor,ARM-30C+,ARM-30M+, ARM-HA101+, ARM-3060, XS Pro, ARM-30G1,ARM-30H,Visomat double comfort Arm Blood Pressure Monitor,ARM-30F-XL, ARM-3024-XL, ARM-3025-XL, ARM-3062-XL, 9S Pro,Visomat comfort 20/40 BT ARM-90B,ARM-90C,ARM-90D Wrist Blood Pressure Monitor AOJ-35C JB9398, JB9510, BW 550, BW 750 connect 3-in-1 Ear, Forehead +Touchless Thermometer, AOJ-20R Infrared Thermometer, AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ- 20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20Y JB9607, TM 550 Arm Blood Pressure MonitorAOJ-30A,AOJ-30B,AOJ-30C,AOJ-30D,AOJ-30E,AOJ-30F,AOJ-30G, ARM-3060 Arm Blood Pressure Monitor AOJ-30H, AHG-300, PRESSURE XS PRO, PRESSURE 9S PRO VivaGuard ARM Blood Pressure Monitor JB9399, BP111, U80X, 9S Pro, XS Pro, BP014US, FBP-A1, CCBPM-30B, CCBPM-30BV, URIGHT ADVANCE Arm Blood Pressure Monitor Deluxe Blood Pressure Kit, Model: BJ120106 Pulse Oximeter,AOJ-70A,AOJ-70B,AOJ-70C,AOJ-70D,AOJ-70E Pulse Oximeter, DMD1066BLK, FPO-F1 Arm Blood Pressure Monitor,models AOJ-33A, AOJ-33B, ARM-33C, ARM-33E CorDx @AL21, Arm Blood Pressure Monitor,ACL21008AOJ-33A Pulse Oximeter PM 550, PM 750 connect, FPO-F1, JB9612 Pulse Oximeter AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D, AOJ-70E Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E 3-in-1 True Temp Thermometer, Quick-Read Rectal Thermometer,DT-25C Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103 Ear Thermometer, EAR-E101, EAR-E102, EAR-E103

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2026-05-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-05-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-04-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-03-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-02-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-12-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-06
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2021-11-14
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2024-08-25
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-07-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-07-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-05-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-10-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-06-30

Official Correspondent

Jack Wang

US Agent Details

Clare Ho Email: cfrhealthcare@foxmail.com Phone: (323) 6333835

Related Public Records

Same Entity

Shenzhen AOJ Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020848330	TELSTAR VIETNAM COMPANY LIMITED	Bac Ninh, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009551875. Last updated year: 2026. Please use registration number 3009551875 when referencing this establishment in official correspondence.