GEN 4 JOY Wheelchair— 510(k) K252370
Substantially EquivalentFree Wheelchair Mission
FDA 510(k) clearance K252370 for GEN 4 JOY Wheelchair, Substantially Equivalent on 2026-07-24. Applicant: Free Wheelchair Mission. Device class: 1.
Summary
Free Wheelchair Mission's GEN 4 JOY Wheelchair is filed under IOR, mechanical wheelchairs. The record doesn't give dimensions or materials.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Free Wheelchair Mission filed from Irvine, California. Review took 359 calendar days (July 30, 2025 to July 24, 2026).
Clearance details
- Applicant
- Free Wheelchair Mission
- 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
- Irvine, CA, US
Recent devices under product code IOR
view allMore clearances from Free Wheelchair Mission
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.