← Product Code [IOR](/productcode/IOR) · K003048

# ALL TERRAIN WHEELCHAIR (ATW) (K003048)

_Roll-Ability (Pty) , Ltd. · IOR · Dec 15, 2000 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K003048

## Device Facts

- **Applicant:** Roll-Ability (Pty) , Ltd.
- **Product Code:** [IOR](/productcode/IOR.md)
- **Decision Date:** Dec 15, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3850
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

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.

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**Source:** [https://fda-staging.innolitics.com/device/K003048](https://fda-staging.innolitics.com/device/K003048)

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