IOR — Wheelchair, Mechanical Class I
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 |
|---|---|---|---|
| K253632 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W50) | January 29, 2026 |
| K251886 | empower ride | EmpowerRide NAVIGATOR | January 12, 2026 |
| K252828 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W47) | December 5, 2025 |
| K252825 | jiangsu jumao x-care medical equipment co., | Manual Wheelchair (W45) | 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 |
| K240120 | turbo wheelchair co | Merlexi Craft Bariatric series of manual wheelchairs | July 5, 2024 |
| K232230 | zhenjiang assure medical equipment co | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; | October 3, 2023 |
| K232198 | zhenjiang assure medical equipment co | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, | September 15, 2023 |
| K232199 | zhenjiang assure medical equipment co | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS | September 15, 2023 |
| K200583 | ki mobility | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | September 5, 2023 |
| K223527 | ki mobility | Little Wave Clik, Rogue XP, Little Wave XP, Spark | August 31, 2023 |
| K231750 | sichuan ast medical equipment co | MA012 Aluminum wheelchair, MS019 steel wheelchair | August 15, 2023 |
| K231110 | ningbo shenyu medical equipment co | Manual Wheelchair (A006) | June 16, 2023 |