LIFELINE(R) PERSONAL RESPONSE SYSTEM— 510(k) K914103
Substantially EquivalentLifeline Systems, Inc.
FDA 510(k) clearance K914103 for LIFELINE(R) PERSONAL RESPONSE SYSTEM, Substantially Equivalent on 1991-09-27. Applicant: Lifeline Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Lifeline Systems, Inc.
- Product code
- Code ILQ
- Device class
- Class 2
- Regulation
- 21 CFR 890.3710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code ILQ
view allMore clearances from Lifeline Systems, Inc.
view allAdverse events under product code ILQ
product code ILQ- Death
- 4
- Malfunction
- 477
- Total
- 481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K914103
K-number listed on FDA's recall record- Z-1316-2018 — HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
- Z-0004-2016 — Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
- Z-1987-2015 — Philips GoSafe Communicator 7000L Personal emergency response system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K914103.
Data sourced from openFDA. This site is unofficial and independent of the FDA.