← Product Code [ILQ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILQ) · K930044

# COMFORT KEYBOARD SYSTEM (K930044)

_Health Care Keyboard Co., Inc. · ILQ · Jul 14, 1994 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILQ/K930044

## Device Facts

- **Applicant:** Health Care Keyboard Co., Inc.
- **Product Code:** [ILQ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILQ.md)
- **Decision Date:** Jul 14, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3710
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILQ/K930044](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILQ/K930044)

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