COMPANION SPEECH AID, MODEL 160— 510(k) K910819

Name: FDA 510(k) clearance K910819
Creator: U.S. Food and Drug Administration
Published: 1991-03-07

Substantially Equivalent

Companion Products Intl.

FDA 510(k) clearance K910819 for COMPANION SPEECH AID, MODEL 160, Substantially Equivalent on 1991-03-07. Applicant: Companion Products Intl.. Device class: 2.

Clearance details

Applicant: Companion Products Intl.
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1991-02-26
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coyote, CA, US

Download summary PDF View on FDA.gov ↗

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K910796 — COMPANION SPEECH AID, MODEL 4321991-03-07

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.