Electric Wheelchair (JLE-W01A-2023)— 510(k) K240255
Substantially EquivalentZhejiang Jianrui Technology Company Limited
FDA 510(k) clearance K240255 for Electric Wheelchair (JLE-W01A-2023), Substantially Equivalent on 2024-08-07. Applicant: Zhejiang Jianrui Technology Company Limited.
Clearance details
- Applicant
- Zhejiang Jianrui Technology Company Limited
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jinhua, CN
Adverse 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.