Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)— 510(k) K261076
Substantially EquivalentGuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
FDA 510(k) clearance K261076 for Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02), Substantially Equivalent on 2026-06-22. Applicant: GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.. Device class: 1.
Summary
This clearance from GuangDong Yong Yi Rehabilitation Equipment Technology covers a caregiver-assisted wheelchair in two models, MS02 and MA02, filed under IOR, mechanical wheelchairs. The record doesn't say how the two models differ.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Yong Yi filed from Zhongshan, China. The decision came 82 calendar days after receipt (April 1 to June 22, 2026).
Clearance details
- Device name as filed
- Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)
- 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 →
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