Manual Wheelchair (MS01); Manual Wheelchair (MA01)— 510(k) K261075
Substantially EquivalentGuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
FDA 510(k) clearance K261075 for Manual Wheelchair (MS01); Manual Wheelchair (MA01), Substantially Equivalent on 2026-06-22. Applicant: GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.. Device class: 1.
Summary
GuangDong Yong Yi Rehabilitation Equipment Technology's clearance covers a manual wheelchair in two models, MS01 and MA01. It's filed under IOR, mechanical wheelchairs, and the record doesn't say how the models differ.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Yong Yi filed from Zhongshan, China. Review took 82 calendar days (April 1 to June 22, 2026).
Clearance details
- Device name as filed
- Manual Wheelchair (MS01);Manual Wheelchair (MA01)
- Applicant
- GuangDong Yong Yi Rehabilitation Equipment 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
- Zhongshan, CN
Recent devices under product code IOR
view allMore clearances from GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
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.