Data / Medical devices / China / Shenzhen Zhimahuaerkai Technology Co., Ltd.
Shenzhen Zhimahuaerkai Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Zhimahuaerkai Technology Co., Ltd. is registered with the FDA (registration 3044425292) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044425292
- Address
- 1002, F1 Building, TCL Technology Park,1001 Zhongshanyuan Rd, Shuguang Community, Xill St, Nanshan District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Zhimahuaerkai Technology Co., Ltd. (10095489)
- Roles
- Manufacturer
- First device listed
- March 19, 2026
- Registered through
- 2026
- Brand names listed
- VEHICLE, MOTORIZED 3-WHEELED, Wheelchair, powered
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 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 |
|---|---|---|---|---|---|---|
| February 24, 2026 | K253707 | Electric wheelchair (W1,W3) | ITI | Substantially Equivalent | Shenzhen Zhimahuaerkai Technology Co., Ltd. | accessdata.fda.gov |
| February 18, 2026 | K253643 | Mobility Scooter (S3) | INI | Substantially Equivalent | Shenzhen Zhimahuaerkai Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 24, 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.