Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3920](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3920) → IMO — Handrim, Wheelchair

# IMO · Handrim, Wheelchair

_Physical Medicine · 21 CFR 890.3920 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMO

## Overview

- **Product Code:** IMO
- **Device Name:** Handrim, Wheelchair
- **Regulation:** [21 CFR 890.3920](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3920)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMO](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMO)

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