510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Shenzhen AOJ Medical Technology Co., Ltd.

Shenzhen Guangdong, CN

Shenzhen AOJ Medical Technology Co., Ltd. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Shenzhen AOJ Medical Technology Co., Ltd. between 2018 and 2026. The busiest year on record is 2022, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Shenzhen AOJ Medical Technology Co., Ltd., by decision year
YearClearances
20182
20191
20201
20225
20232
20241
20254
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
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 ProDXNSubstantially Equivalent
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLLSubstantially Equivalent
K250161Wrist 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 BlooDXNSubstantially Equivalent
K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);DXNSubstantially Equivalent
K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)DXNSubstantially Equivalent
K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)DQASubstantially Equivalent
K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)FLLSubstantially Equivalent
K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BDXNSubstantially Equivalent
K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20YFLLSubstantially Equivalent
K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDXNSubstantially Equivalent
K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107FLLSubstantially Equivalent
K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EFLLSubstantially Equivalent
K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EDXNSubstantially Equivalent
K202173Pulse OximeterDQASubstantially Equivalent
K191180Electronic Blood Pressure MonitorDXNSubstantially Equivalent
K182190Fetal DopplerKNGSubstantially Equivalent
K182133Infrared ThermometerFLLSubstantially Equivalent

Registered establishments

FDA registered establishments for Shenzhen AOJ Medical Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30095518753009551875Shenzhen AOJ Medical Technology Co., Ltd.Room 301&4-5F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Shenzhen Guangdong 518126 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Shenzhen AOJ Medical Technology Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain