Scout Boss 4.5 TPB

Scout Boss 4.5 TPB (82389) is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Burke, Inc., cleared under FDA 510(k) K023961 on 24 Dec 2002 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI B314823891), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB314823891 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK023961	Date24 Dec 2002Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K023961

Across registries

2 registries list this device

FDA 510(k) K023961 decided 24 Dec 2002 Active
FDA GUDID UDI-DI B314823891 listed 1 Sep 2016 Listed

Timeline

2 dated events

24 Dec 2002 Cleared FDA 510(k) K023961
1 Sep 2016 Listed FDA GUDID B314823891

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Scout
Generic name: Electric-motor-driven wheelchair, occupant-controlled
Model / Ref / Catalog: Boss 4.5 TPB, 82389

Primary DI / UDI-DI: B314823891
510(k) Number: K023961
FDA product code: ITI
GMDN term: Electric-motor-driven wheelchair, occupant-controlled

Device class: Class II
Regulation number: 890.3860
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.

Other devices from Burke, Inc.

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Properties

Serial number
Manufacturing date

Other properties (13, all answered No)