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Companion Speech Aid, Model 432

by Companion Products Intl.

510(k) K910796

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910796 Date7 Mar 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILQ
Device Class
Class II
Regulation
21 CFR Part 890.3710
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Companion Speech Aid, Model 432 is a powered communication system device designed to assist with speech. It is classified under the product code ILQ and is intended for use in physical medicine settings.

This device is authorized under FDA 510(k) clearance K910796 with a decision date of March 7, 1991. The device is manufactured by Companion Products Intl. and is registered under multiple registration numbers. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the device data.

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