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Sign in to claim this brandWhat LIFELINES LIMITED makes
Lifelines Limited manufactures electroencephalographic devices, including ambulatory recorders for continuous EEG monitoring, standalone electroencephalographs for clinical use, and polysomnographs for sleep studies. Their product line includes portable and battery-powered systems like the Trackit series (e.g., Trackit T4, Trackit Sleepwalker, and Trackit Battery Box) and wired models such as the R-40 (24-channel) for long-term EEG recording.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Lifelines Limited operates from the United States, adhering to applicable medical device compliance standards for diagnostic and monitoring equipment.
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 Lifelines Limited manufacture?
Lifelines Limited specializes in electroencephalographic (EEG) devices, including ambulatory recorders for continuous monitoring, standalone electroencephalographs for clinical use, and polysomnographs for sleep studies. Their product line covers portable and battery-powered systems like the Trackit series (e.g., Trackit T4, Trackit Sleepwalker) as well as wired models such as the R-40 (24-channel) for extended EEG recording. These devices are designed for diagnostic purposes in neurological and sleep medicine.
Where is Lifelines Limited based?
Lifelines Limited is based in the United States. The company develops and manufactures its devices from this location, ensuring compliance with U.S. medical device regulations and standards.
Which regulatory registries list Lifelines Limited’s devices?
Lifelines Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II medical devices, ensuring transparency and traceability in the regulatory and clinical environments.
How are Lifelines Limited’s devices classified under FDA regulations?
Lifelines Limited’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as EEG monitoring systems used for diagnostic purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- llines.com
- —
- —
- [email protected]
- Phone
- +441483224245
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 237089235
Catalogue (65)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trackit | Trackit 3 BT 12/0 | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier Kit | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + BT + WI-FI | FDA UDI | Class II | Active |
| Trackit T4 | T4-32 + BT + WI-FI | FDA UDI | Class II | Active |
| R-40 (24) | Amp Kit | FDA UDI | Class II | Active |
| Trackit T4 | T4-68 + WI-FI | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 + BT Kit | FDA UDI | Class II | Active |
| R-40 (24) | Amp + BT Kit | FDA UDI | Class II | Active |
| Trackit Battery Box | LI | FDA UDI | Class II | Active |
| R-40 (24) | Amp + WI-FI Kit | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + WI-FI Kit | FDA UDI | Class II | Active |
| Trackit PCU | Sleep Clickon PCU +SAO2 | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + WI-FI | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 20/4 | FDA UDI | Class II | Active |
| R-40 (24) | Amp | FDA UDI | Class II | Active |
| R-40 (24) | Amp + BT | FDA UDI | Class II | Active |
| Trackit T4 | T4-68 Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 24/8 | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 + SaO2 + BT | FDA UDI | Class II | Active |
| Trackit | Trackit 20/4/B Kit | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + BT Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 24/8 Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 20/4/B | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + BT + WI-FI Kit | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 + BT | FDA UDI | Class II | Active |
| Trackit T4 | T4-32 Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 24/8/B | FDA UDI | Class II | Active |
| Trackit T4 | T4-32 | FDA UDI | Class II | Active |
| R-40 (24) | Amp + WI-FI | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 24/0/B | FDA UDI | Class II | Active |
| Trackit T4 | T4-68 | FDA UDI | Class II | Active |
| Trackit | Trackit 12/0/B Kit | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 Standard | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 32/0 | FDA UDI | Class II | Active |
| Trackit T4 | T4-68 + BT + WI-FI | FDA UDI | Class II | Active |
| Trackit | Trackit 18/8 Kit | FDA UDI | Class II | Active |
| Trackit T4 | T4-32 + WI-FI Kit | FDA UDI | Class II | Active |
| Trackit T4 | T4-32 + WI-FI | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 + SaO2 Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 18/8/B | FDA UDI | Class II | Active |
| R-40 (24) | Amp + BT + WI-FI | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 18/8 | FDA UDI | Class II | Active |
| Trackit T4 | T4-68 + BT + WI-FI Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 12/0/B | FDA UDI | Class II | Active |
| Trackit PCU | Short Clickon PCU | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 + SaO2 | FDA UDI | Class II | Active |
| Trackit | Trackit 24/8/B Kit | FDA UDI | Class II | Active |
| Trackit Sleepwalker | MK3 Standard Kit | FDA UDI | Class II | Active |
| Trackit | Trackit 3 BT 32/0/B | FDA UDI | Class II | Active |
| R-40 | EEG Amplifier + BT | FDA UDI | Class II | Active |
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