TOUCH TALKER— 510(k) K914259

Name: FDA 510(k) clearance K914259
Creator: U.S. Food and Drug Administration
Published: 1992-02-27

Substantially Equivalent

Prentke Romich Co.

FDA 510(k) clearance K914259 for TOUCH TALKER, Substantially Equivalent on 1992-02-27. Applicant: Prentke Romich Co.. Device class: 2.

Clearance details

Applicant: Prentke Romich Co.
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1991-09-23
Decision date: 1992-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wooster, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Prentke Romich Co.

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K961306 — DELTATALKER WITH INFRARED1996-06-27
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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.