Data / Medical devices / China / Jiangxi Aicare Medical Technology Co., Ltd
Jiangxi Aicare Medical Technology Co., Ltd: FDA-registered device maker in Fuzhou Jiangxi, China, 2 510(k) clearances
Jiangxi Aicare Medical Technology Co., Ltd is registered with the FDA (registration 3016630774) in Fuzhou Jiangxi, China. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016630774
- Address
- No.6, South Side of Nanhuan Road Qianping Industrial Park Le'an County, Fuzhou Jiangxi, China, 344300
- Owner or operator
- Jiangxi AICARE Medical Technology Co., Ltd (10065465)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 29, 2020
- Registered through
- 2026
- Brand names listed
- Electronic Sphygmomanometers ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11, Face mask, Infrared Forehead Thermometers A66, A68, A69, Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108, Sunglasses, fingertip pulse oximeter W011; fingertip pulse oximeter W013, hearing aid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 14, 2025 | K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | DXN | Substantially Equivalent | Jiangxi Aicare Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 31, 2022 | K221040 | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) | DXN | Substantially Equivalent | Jiangxi Aicare Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Clinical Electronic Thermometer
- All makers of Unit, Oral Irrigation
Updated July 14, 2025. 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.