IOR — Wheelchair, Mechanical Class I
FDA product code IOR covers "Wheelchair, Mechanical", a Class I medical device regulated under 21 CFR 890.3850. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IOR
- Device Class
- Class I
- Regulation Number
- 890.3850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261076 | guangdong yong yi rehabilitation equipment technology co | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | June 22, 2026 |
| K261075 | guangdong yong yi rehabilitation equipment technology co | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | June 22, 2026 |
| K260849 | rehasense usa | ICON 35; ICON 45; ICON 60; ICON 30FAF | June 11, 2026 |
| K260642 | anhui longway medical technology co | Manual Wheelchair (LW01108) | June 2, 2026 |
| K260295 | motion composites | Helio Kids; Apex P | May 28, 2026 |
| K254141 | guangdong dayang medical technology co | Manual Wheelchair (DY01903(2)) | May 21, 2026 |
| K260121 | foshan nanhai hongchen medical equipment co | Manual Wheelchair (7101L, 7102LHD) | April 28, 2026 |
| K260319 | zhenjiang assure medical equipment co | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 wit | March 31, 2026 |
| K253632 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W50) | January 29, 2026 |
| K251886 | empower ride | EmpowerRide NAVIGATOR | January 12, 2026 |
| K252825 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W45) | December 5, 2025 |
| K252828 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W47) | December 5, 2025 |
| K252687 | suzhou master machinery manufacturing co | Manual Wheelchair (HM305-Air1, HM305-Air2) | November 21, 2025 |
| K250576 | karma mobility co | Flexx Junior (FLX-J00, FLX-J50) | November 4, 2025 |
| K252517 | ningbo shenyu medical equipment co | Manual Wheelchair (SYIV100A008) | October 3, 2025 |
| K241374 | anhui jbh medical apparatus co | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | February 28, 2025 |
| K243111 | bowhead design | Bowhead ERA Wheelchairs | January 10, 2025 |
| K242722 | sichuan ast medical equipment co | Manual Wheelchair (MASY23) | November 22, 2024 |
| K242560 | foshan shunkangda medical tech co | Manual Wheelchair (SYIV100-CA9221) | October 24, 2024 |
| K241460 | lichtmega technology co | Manual Wheelchair | July 11, 2024 |