Lifelines Neuro Company
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
Devices registered here (2)
- Amplifier, Physiological SignalProduct code GWL (opens in a new tab) · Class II · Neurology · 21 CFR 882.1835
- Full-Montage Standard ElectroencephalographProduct code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
Recalls & enforcement
- Class IITerminated2019-10-11Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrode for an EEG study.
FDA inspections (2)
- NAI2024-10-18No Action Indicated · Compliance: Devices
- NAI2022-02-18No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Lifelines Neuro Company (FEI 3015491430) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015491430-lifelines-neuro-company/
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