Data / Medical devices / China / Shenzhen AOJ Medical Technology Co., Ltd.
Shenzhen AOJ Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 12 510(k) clearances
Shenzhen AOJ Medical Technology Co., Ltd. is registered with the FDA (registration 3009551875) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009551875
- Address
- Room 301&4-5F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community Xixiang Street, Baoan District, Shenzhen Guangdong, China, 518126
- Owner or operator
- Shenzhen AOJ Medical Technology Co., Ltd. (10059056)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 14, 2021
- Registered through
- 2026
- Brand names listed
- 3-in-1 Ear, Forehead +Touchless Thermometer, AOJ-20R, 3-in-1 True Temp Thermometer, Quick-Read Rectal Thermometer,DT-25C, 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-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, ARM-90B,ARM-90C,ARM-90D,MM-BP-5000,ARM-3083, Arm Blood Pressure Monitor AOJ-30H, AHG-300, PRESSURE XS PRO, PRESSURE 9S PRO, Arm Blood Pressure Monitor, ARM-30G+, ARM-30M,ARM-30S,ARM-30T,ARM-HA101, BU 550, Arm Blood Pressure Monitor, ARM-30H, ARM-30J, ARM-30K, ARM-90B, BU 750 connect,BU 800 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2026 | K260276 | Arm 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 Pro | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 23, 2025 | K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 2, 2025 | K250161 | 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 | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 30, 2025 | K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 24, 2025 | K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2024 | K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 14, 2023 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 26, 2023 | K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 1, 2022 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 7, 2022 | K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 25, 2022 | K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Oximeter, Wellness
- All makers of Clinical Electronic Thermometer
Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.