Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)— 510(k) K232193
Substantially EquivalentYurob Rehabilitation Medical Co., Ltd.
FDA 510(k) clearance K232193 for Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03), Substantially Equivalent on 2023-09-22. Applicant: Yurob Rehabilitation Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Yurob Rehabilitation Medical Co., Ltd.
- Product code
- 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
- Kunshan, CN
Recent devices under product code ITI
view allMore clearances from Yurob Rehabilitation Medical 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.