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Better Life Technologies MT-108

by Better Life Technologies LLC

Better Life Technologies MT-108 is a Class II device made by Better Life Technologies LLC, cleared under FDA 510(k) K041516 on 8 Sep 2004 and listed in FDA GUDID since 15 Aug 2020 (UDI-DI 00850004257012), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K041516

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850004257012 UDI-DI Date15 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041516 Date8 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041516 decided 8 Sep 2004 Active
  • FDA GUDID UDI-DI 00850004257012 listed 15 Aug 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0506-2012 FDA Unclassified (pre-2012) initiated 23 Nov 2011

    The thermometers have been reported to have inaccurate readings

Timeline

3 dated events

  1. Cleared FDA 510(k) K041516
  2. Recall initiated FDA recalls Z-0506-2012
  3. Listed FDA GUDID 00850004257012

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Better Life Technologies
Generic name
Intermittent electronic patient thermometer
Model / reference
MT-108
Primary DI / UDI-DI
00850004257012
510(k) Number
FDA product code
FLL
GMDN term
Intermittent electronic patient thermometer
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Intermittent electronic patient thermometer.

Properties

  • Lot / batch number
Other properties (14, all answered No)