Electric wheelchair— 510(k) K253307
Substantially EquivalentFoshan Dahao Medical Technology Co., Ltd.
FDA 510(k) clearance K253307 for Electric wheelchair, Substantially Equivalent on 2026-03-27. Applicant: Foshan Dahao Medical Technology Co., Ltd.. Device class: 2.
Summary
Foshan Dahao Medical Technology's Electric wheelchair is filed under ITI, powered wheelchairs. The name is generic, and the record doesn't give a model number.
Class II, 21 CFR 890.3860. It was a Traditional 510(k), and Physical Medicine is both the classification panel and the review panel.
Foshan Dahao Medical Technology filed from Foshan, China. The decision came 179 calendar days after FDA received it (September 29, 2025 to March 27, 2026).
Clearance details
- Applicant
- Foshan Dahao Medical 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
- Foshan, CN
Recent devices under product code ITI
view allMore clearances from Foshan Dahao Medical 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.