Data / Medical devices / United Kingdom / Lifelines Ltd.
Lifelines Ltd.: FDA-registered device maker in WOKING Surrey, United Kingdom, 4 510(k) clearances
Lifelines Ltd. is registered with the FDA (registration 9710486) in WOKING Surrey, United Kingdom. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 4, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710486
- FEI number
- 3003501123
- Address
- 1 Tannery House, Tannery Lane, WOKING Surrey, United Kingdom, GU23 7EF
- Owner or operator
- LIFELINES LTD. (9044781)
- Roles
- Specification developer
- First device listed
- August 21, 2001
- Registered through
- 2026
- Brand names listed
- Lifelines Photic Stimulator, Photic, R-40 EEG Amplifier, TRACK IT, Trackit MK3, Trackit T4 EEG Amplifier, Trackit T4A EEG Amplifier
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Specification developer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Specification developer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2018 | K172271 | Trackit T4 EEG Amplifier | GWQ | Substantially Equivalent | Lifelines , Ltd. | accessdata.fda.gov |
| October 23, 2015 | K151600 | R-40 EEG Amplifier | GWL | Substantially Equivalent | Lifelines , Ltd. | accessdata.fda.gov |
| August 10, 2010 | K101691 | LIFELINES PHOTIC STIMULATOR | GWE | Substantially Equivalent | Lifelines , Ltd. | accessdata.fda.gov |
| May 14, 2001 | K010460 | LIFELINES TRACKIT | OLV | Substantially Equivalent | Lifelines , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Photic, Evoked Response
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Amplifier, Physiological Signal
Updated May 4, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.