Electric wheelchair (W1,W3)— 510(k) K253707
Substantially EquivalentShenzhen Zhimahuaerkai Technology Co., Ltd.
FDA 510(k) clearance K253707 for Electric wheelchair (W1,W3), Substantially Equivalent on 2026-02-24. Applicant: Shenzhen Zhimahuaerkai Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Zhimahuaerkai Technology's Electric wheelchair lists two models, W1 and W3, under product code ITI, powered wheelchair. The record doesn't say how they differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Shenzhen Zhimahuaerkai Technology filed from Shenzhen, China. The decision came 92 calendar days after FDA received it (November 24, 2025 to February 24, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shenzhen Zhimahuaerkai Technology Co., Ltd.
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code ITI
view allMore clearances from Shenzhen Zhimahuaerkai Technology Co., Ltd.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.