# Wheelchair, Mechanical
> **Product code: IOR** · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3850
## Classification
- **FDA Product Code:** IOR
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 890.3850
- **Review panel:** PM
- **Medical specialty:** Physical Medicine
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 455
- **Registered establishments:** 127
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=IOR)
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