RegWardenFDA facility compliance records
Facility

LIFELINES LTD.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 inspections; 2019: 1 recalls201712018120192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (2)

  • Full-Montage Standard Electroencephalograph
    Product code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
  • Standard Polysomnograph With Electroencephalograph
    Product code OLV (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400

Recalls & enforcement

  • Class IITerminated2019-10-11
    Potential 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 (1)

  • VAI2018-04-17
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 LTD. (FEI 3003501123) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003501123-lifelines-ltd/

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