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Lifeline Systems, Inc.

US

Last updated May 23, 2026

What Lifeline Systems, Inc. makes

Lifeline Systems, Inc. manufactures medical alert systems designed for vulnerable patients in home settings, including wearable pendants, wristbands, and DECT-based communication devices. Their portfolio also includes reusable nasal masks for CPAP/BPAP therapy, such as the Philips GoSafe and BlueBand models. These systems are intended to provide emergency response capabilities for seniors or individuals with mobility limitations, while the masks support continuous positive airway pressure treatment.

The company’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. Their products are intended for use within the United States, where they are subject to compliance with FDA requirements for medical alert systems and respiratory therapy masks.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Lifeline Systems, Inc. manufacture?

Lifeline Systems, Inc. specializes in two primary categories of medical devices. First, they produce vulnerable patient home alert systems, such as wearable pendants, wristbands, and DECT-based communicators (e.g., AutoAlert with Indicator, HomeSafe AutoAlert Pendant). These devices are designed to enable emergency response for individuals with limited mobility or seniors. Second, they manufacture reusable nasal masks for CPAP/BPAP therapy, including models like the Philips GoSafe and Philips BlueBand, which support continuous positive airway pressure treatment.

Where is Lifeline Systems, Inc. based, and what does that mean for its devices?

Lifeline Systems, Inc. is based in the United States. This means their devices are developed and marketed primarily within the US regulatory framework, where they must comply with FDA requirements for medical alert systems and respiratory therapy masks. The company’s focus on US-based products ensures alignment with local safety, performance, and labeling standards.

Which regulatory registries list Lifeline Systems, Inc.’s devices?

Lifeline Systems, Inc.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) registry tracks premarket submissions for devices deemed substantially equivalent to existing cleared products, while the UDI registry ensures traceability and identification of medical devices through standardized labeling. These listings reflect compliance with US regulatory pathways for Class II devices.

How are Lifeline Systems, Inc.’s devices classified under US regulations?

Lifeline Systems, Inc.’s devices are classified as Class II under the US FDA regulatory system. Class II devices require special controls to ensure their safety and effectiveness but do not pose the highest risk (unlike Class III). The company’s home alert systems and CPAP/BPAP nasal masks fall into this category because they involve moderate risk—such as potential misuse of emergency alerts or improper mask fit—but do not require the stringent premarket approval process of Class III devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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EUDAMED SRN
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Catalogue (96)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Senior Living Alert Device AutoAlert with Indicator 300000999281
FDA UDI
Class IIActive
PHB, Autoalert, Japan - Primary 1840501
FDA UDI
Class IIUnknown
Philips GoSafe 300000188981
FDA UDI
Class IIActive
GoSafe / HomeSafe Personal Help Wriststrap 300000267981
FDA UDI
Class IIActive
Senior Living Alert Device AutoAlert with Indicator 300000491151
FDA UDI
Class IIActive
DECT Handset HAC 1840560
FDA UDI
Class IIActive
Slimline Personal Help Wriststrap 1840440
FDA UDI
Class IIActive
Senior Living Alert DevicePersonal Help Pendant with Indicator 300000504891
FDA UDI
Class IIUnknown
Senior Living Alert Device AutoAlert with Indicator 300000350661
FDA UDI
Class IIUnknown
Philips BlueBand 300004069001
FDA UDI
Class IIActive
HomeSafe Standard Personal Help Wriststrap 300005057771
FDA UDI
Class IIActive
HomeSafe AutoAlert Pendant 300001144871
FDA UDI
Class IIActive
Senior Living Alert Device Personal Help Wriststrap with Indicator 1840580
FDA UDI
Class IIActive
HomeSafe AutoAlert Pendant 1840511
FDA UDI
Class IIActive
DECT Telephone HAC Communicator 1840463
FDA UDI
Class IIActive
GoSafe / HomeSafe Personal Help Wriststrap 1840539
FDA UDI
Class IIActive
Philips GoSafe Mobile Help Button 1840525
FDA UDI
Class IIActive
Philips GoSafe 2 300002566981
FDA UDI
Class IIActive
Philips GoSafe 300000042511
FDA UDI
Class IIUnknown
HomeSafe Standard Smoke Detector 1890040
FDA UDI
Class IIUnknown
CarePartner Home Communicator 1840476
FDA UDI
Class IIActive
HomeSafe AutoAlert Pendant 1840531
FDA UDI
Class IIActive
HomeSafe AutoAlert Pendant 300000340121
FDA UDI
Class IIActive
Senior Living Personal Help Device Wriststrap 300005057731
FDA UDI
Class IIActive
HomeSafe (Landline) Home Communicator 1840565
FDA UDI
Class IIActive
Senior Living Alert Device Personal Help Pendant with Indicator 1840579
FDA UDI
Class IIActive
Senior Living Alert Device Personal Help Wriststrap with Indicator 300004873351
FDA UDI
Class IIActive
Senior Living Alert Device Personal Help Wriststrap with Indicator 300000270951
FDA UDI
Class IIActive
Senior Living Personal Help Device Wriststrap 300001287701
FDA UDI
Class IIActive
Senior Living Voice Communicator 1890076
FDA UDI
Class IIUnknown
GoSafe / HomeSafe AutoAlert Pendant 1840532
FDA UDI
Class IIActive
GoSafe / HomeSafe AutoAlert Pendant 300000491131
FDA UDI
Class IIActive
HomeSafe Standard Home Communicator 1840549
FDA UDI
Class IIActive
HomeSafe Standard Classic Personal Help Pendant 1840481
FDA UDI
Class IIActive
Senior Living Alert Device AutoAlert 300000491121
FDA UDI
Class IIActive
HomeSafe Standard Adaptable Transmitter 1900408
FDA UDI
Class IIActive
GoSafe / HomeSafePersonal Help Wriststrap 300000504851
FDA UDI
Class IIUnknown
DECT Telephone HAC Communicator 1840469
FDA UDI
Class IIActive
GoSafe / HomeSafe Personal Help Wriststrap 300004873331
FDA UDI
Class IIActive
Senior Living Personal Help Device Pendant 300005057751
FDA UDI
Class IIActive
Senior Living Alert DevicePersonal Help Pendant 1840487
FDA UDI
Class IIActive
Lifeline Response App 300000161311
FDA UDI
Class IIUnknown
HomeSafe Standard Home Communicator 1840551
FDA UDI
Class IIActive
Senior Living Alert Device Personal Help Pendant with Indicator 300004873321
FDA UDI
Class IIActive
Senior Living Alert DevicePersonal Help Pendant with Indicator 300000504831
FDA UDI
Class IIUnknown
Senior Living Alert Device AutoAlert 1840534
FDA UDI
Class IIActive
Philips GoSafe 2 300002706311
FDA UDI
Class IIActive
Philips GoSafe 2 300000189031
FDA UDI
Class IIActive
Philips Medication Dispenser 1900741
FDA UDI
Class IIActive
GoSafe / HomeSafe AutoAlert Pendant 300000350611
FDA UDI
Class IIUnknown

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Lifeline Systems, Inc. has one recall record initiated on November 13, 2017, which is marked as terminated. The recall pertains to a programming error in certain Model FD100 HomeSafe AutoAlert Pendants that may affect the fall detection feature.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Nov 13, 2017Z-1316-2018—terminated

A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.