Electric Wheelchair (E201)— 510(k) K254012
Substantially EquivalentNanjing CareMoving Rehabilitation Equipment Co.,Ltd
FDA 510(k) clearance K254012 for Electric Wheelchair (E201), Substantially Equivalent on 2026-03-24. Applicant: Nanjing CareMoving Rehabilitation Equipment Co.,Ltd. Device class: 2.
Summary
Nanjing CareMoving Rehabilitation Equipment's Electric Wheelchair (E201) is filed under ITI, powered wheelchairs. The name is generic apart from the E201 designation.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nanjing CareMoving Rehabilitation Equipment filed from Nanjing, China. Review took 99 calendar days (December 15, 2025 to March 24, 2026).
Clearance details
- Applicant
- Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
- Product code
- Product 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
- Nanjing, CN
Recent devices under product code ITI
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.