LIFELINE(R) PERSONAL RESPONSE SYSTEM— 510(k) K914103

Substantially Equivalent

Lifeline Systems, Inc.

FDA 510(k) clearance K914103 for LIFELINE(R) PERSONAL RESPONSE SYSTEM, Substantially Equivalent on 1991-09-27. Applicant: Lifeline Systems, Inc..

Clearance details

Applicant: Lifeline Systems, Inc.
Product code: Code ILQ
Advisory panel: Physical Medicine
Date received: 1991-09-12
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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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.