Manual Wheelchair (DY01903(2))— 510(k) K254141
Substantially EquivalentGuangdong Dayang Medical Technology Co., Ltd.
FDA 510(k) clearance K254141 for Manual Wheelchair (DY01903(2)), Substantially Equivalent on 2026-05-21. Applicant: Guangdong Dayang Medical Technology Co., Ltd.. Device class: 1.
Summary
Guangdong Dayang Medical Technology's Manual Wheelchair (DY01903(2)) is filed under IOR, mechanical wheelchairs. Apart from the model number, the name is generic.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).
Dayang filed from Foshan, China. Review took 150 calendar days (December 22, 2025 to May 21, 2026).
Clearance details
- Applicant
- Guangdong Dayang Medical Technology Co., Ltd.
- Product code
- Product code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Recent devices under product code IOR
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
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.