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Trackit 3 BT 18/8

by Lifelines Limited

Trackit 3 BT 18/8 (1185) is a Class II device made by Lifelines Limited, cleared under FDA 510(k) K010460 on 14 May 2001 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 05060275450028), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K010460

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060275450028 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) from GUDID NumberK010460 Date14 May 2001IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010460 decided 14 May 2001 Active
  • FDA GUDID UDI-DI 05060275450028 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010460
  2. Listed FDA GUDID 05060275450028

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trackit
Generic name
Electroencephalographic ambulatory recorder
Model / Ref / Catalog
Trackit 3 BT 18/8, 1185
Primary DI / UDI-DI
05060275450028
510(k) Number
FDA product code
GWQ
GMDN term
Electroencephalographic ambulatory recorder
Device class
Class II
Regulation number
882.1400
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Electroencephalographic ambulatory recorder

Similar devices

Other devices filed under FDA product code GWQ (Full-Montage Standard Electroencephalograph).

Other devices from Lifelines Limited

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)