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) → LFF — Unit, Activation, Breath Control

# LFF · Unit, Activation, Breath Control

_Physical Medicine · 21 CFR 890.3920 · Class 1_

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

## Overview

- **Product Code:** LFF
- **Device Name:** Unit, Activation, Breath Control
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964977](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/LFF/K964977.md) | IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) | Interactive Living Systems, Inc. | Aug 31, 1998 | SESE |

## Top Applicants

- Interactive Living Systems, Inc. — 1 clearance

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

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