Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Philips GoSafe	300000367071	FDA UDI	Class II	Active
GoSafe / HomeSafe Personal Help Pendant	300004873261	FDA UDI	Class II	Active
HomeSafe Standard Slimline Personal Help Wriststrap	1840482	FDA UDI	Class II	Active
Senior Living Personal Help Device Pendant	300001287691	FDA UDI	Class II	Active
HomeSafe Standard Slimline Personal Help Wriststrap	1840480	FDA UDI	Class II	Active
HomeSafe AutoAlert Pendant	300000219841	FDA UDI	Class II	Active
Senior Living Alert Device Personal Help Wriststrap	1840486	FDA UDI	Class II	Active
HomeSafe Standard Personal Help Pendant	300001287651	FDA UDI	Class II	Active
Senior Living Alert Device AutoAlert with Indicator	1840578	FDA UDI	Class II	Active
HomeSafe (Wireless) Home Communicator	1840541	FDA UDI	Class II	Active
Senior Living Alert Device AutoAlert	300000340591	FDA UDI	Class II	Active
HomeSafe Standard Voice Extension	1840458	FDA UDI	Class II	Active
HomeSafe Standard Personal Help Pendant	300005057791	FDA UDI	Class II	Active
Senior Living Alert Device AutoAlert	300001144881	FDA UDI	Class II	Active
HomeSafe (Wireless) Home Communicator	300003472821	FDA UDI	Class II	Active
HomeSafe Standard Home Communicator	1840550	FDA UDI	Class II	Active
Senior Living Alert Device Personal Help Pendant with Indicator	300000267941	FDA UDI	Class II	Active
HomeSafe Standard Home Communicator	300002985651	FDA UDI	Class II	Active
DECT Telephone Handset/Charger	1890099	FDA UDI	Class II	Active
HomeSafe Standard Home Communicator	300003336611	FDA UDI	Class II	Active
Senior Living Alert Device AutoAlert	1840563	FDA UDI	Class II	Active
HomeSafe Standard Personal Help Wriststrap	300001287661	FDA UDI	Class II	Active
HomeSafe AutoAlert Pendant	1840561	FDA UDI	Class II	Active
GoSafe / HomeSafePersonal Help Pendant	300000504781	FDA UDI	Class II	Unknown
HomeSafe Standard Voice Extension	1840367	FDA UDI	Class II	Active
Philips GoSafe 2	300000103361	FDA UDI	Class II	Unknown
GoSafe / HomeSafe Personal Help Pendant	300000264211	FDA UDI	Class II	Active
HomeSafe AutoAlert Pendant	1840421	FDA UDI	Class II	Unknown
Senior Living CareConnect Communicator	1890089	FDA UDI	Class II	Active
Philips GoSafe	300002566971	FDA UDI	Class II	Active
DECT Telephone Home Communicator	1890109	FDA UDI	Class II	Active
DECT Telephone Voice Extension	1840402	FDA UDI	Class II	Active
GoSafe / HomeSafe Personal Help Pendant	1840537	FDA UDI	Class II	Active
HomeSafe AutoAlert Pendant	300000491111	FDA UDI	Class II	Active
Lifeline Response App	300000161331	FDA UDI	Class II	Unknown
HomeSafe Standard Slimline Personal Help Wriststrap	1840478	FDA UDI	Class II	Active
HomeSafe (Landline) Home Communicator	1840542	FDA UDI	Class II	Active
HomeSafe (Wireless) Home Communicator	1840564	FDA UDI	Class II	Active
Slimline Personal Help Wriststrap	1840235	FDA UDI	Class II	Active
GoSafe / HomeSafe AutoAlert Pendant	300000999261	FDA UDI	Class II	Active
HomeSafe AutoAlert Pendant	300000219851	FDA UDI	Class II	Active
ComfortGel	00	FDA UDI	Class II	Active
Single Bed Arrhythmia Monitor Am500	K831638	FDA 510(k)	Class II	Active
Blood Pressure Monitor Bp600x	K834441	FDA 510(k)	Class II	Active
M3810a Philips Telemonitoring System With Edevice Bridged130	K103214	FDA 510(k)	Class II	Active
Lifeline(r) Personal Response System	K914103	FDA 510(k)	Class II	Active

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