AOJ Health Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 9 device types, 1 clearance.
AOJ Health Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Pad, Heating, Powered and 7 other device types. Its earliest product listing with the FDA dates from 2023.
9device types registered with the FDA
1510(k) clearance
Registration
| Registered name | AOJ HEALTH TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3020994856 |
| FEI number | 3020994856 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市奥极健康科技有限公司 |
|---|---|
| Unified social credit code | 91440300MA5H3WFHXE |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Baoan District |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | Class 2 | Nasal Aspirator ASP-401, Nasal Aspirator ASP-402 | 2026 | 88 |
| Catheters, Suction, Tracheobronchial | Class 1 | Nasal Aspirator ASP-402, Nasal Aspirator ASP-401 | 2024 | 93 |
| Cleaner, Denture, Mechanical | Class 1 | Ultrasonic Cleaner USC-20, Ultrasonic Cleaner USC-10 | 2024 | 12 |
| Irrigator, Powered Nasal | Class 1 | Atomizing Nasal Irrigator ANI-801, ANI-802, ANI-803, ANI-804 | 2025 | 63 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Compressor Nebulizer, models NEB-CP01,NEB-CP03, NEB-CP04, NEB-MP01, NEB-MP02, NEB-MP03, NEB-MP04, NEB-MP05 | 2026 | 57 |
| Otoscope | Class 1 | Otoscope OT-501, Otoscope OT-503, Ear Wax Removal Tool Camera EWR-10, EWR-50 | 2023 | 43 |
| Pad, Heating, Powered | Class 2 | Insect Bite Healer IBR70, IBR75, IBR80, BR100, BR200, BR70, BR75, IBR600, IBR700, IBR800, IBR900, Insect Bite Healer IBR 10, IBR 20, IBR 30, IBR 40, IBR 50, IBR 60, Insect Bite Healer IB 50E, IB 80, IB 100, IB 150, IB 200,IB A50, IB 550, CorDx @AL21, Insect Bite Healer, ACL21011IBR40 | 2023 | 144 |
| Pump, Breast, Non-Powered | Class 1 | Manual Breast Pump BRP-101 | 2025 | 33 |
| Pump, Breast, Powered | Class 2 | Electric Breast Pump (BRP-301, 302, 303, 304, 305, 306, 307, 308, 201, 202, 203) | 2024 | 40 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233913 | 2024-05-14 | HGX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Arm Blood Pressure Monitors, Wrist Blood Pressure Monitors, Pulse Oximeters, Infrared Thermometers, Breast Pumps |
| Export markets | 60+ countries and regions |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.