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Pacesaver Fusion 450

by Burke, Inc.

Pacesaver Fusion 450 (15085) is an assistive scooter (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Burke, Inc., cleared under FDA 510(k) K061912 on 1 Aug 2006 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI B314150851), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K061912

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 NumberB314150851 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061912 Date1 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061912 decided 1 Aug 2006 Active
  • FDA GUDID UDI-DI B314150851 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061912
  2. Listed FDA GUDID B314150851

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pacesaver
Generic name
Assistive scooter, electric-motor-driven
Model / Ref / Catalog
Fusion 450, 15085
Primary DI / UDI-DI
B314150851
510(k) Number
FDA product code
INI
GMDN term
Assistive scooter, electric-motor-driven
Device class
Class II
Regulation number
890.3800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assistive scooter, electric-motor-driven

Cleared under the same submission (K061912)

Similar devices

Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).

Other devices from Burke, Inc.

See all devices from Burke, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)