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Scout Boss

by Burke, Inc.

510(k) K023961

Scout Boss is a medical device (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Burke, Inc., cleared under FDA 510(k) K023961 on 24 Dec 2002, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023961 Date24 Dec 2002ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ITI
Device class
Class II
Regulation
21 CFR Part 890.3860
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Devices cleared under K023961

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K023961
UDI-DISize and differences
Scout Boss 4.5 N/S
Burke, Inc.
82348 / Boss 4.5 N/SB314823481 —On the market
Scout Boss 4.5 TPB
Burke, Inc.
82389 / Boss 4.5 TPBB314823891 —On the market
Scout Boss 6
Burke, Inc.
82628 / Boss 6B314826281 —On the market
Scout Boss 6 TPB
Burke, Inc.
82676 / Boss 6 TPBB314826761 —On the market
Scout Boss 6.75
Burke, Inc.
82062 / Boss 6.75B314820621 —On the market
Scout Boss 6.75 TPB
Burke, Inc.
82677 / Boss 6.75 TPBB314826771 —On the market
Scout Boss 6NS
Burke, Inc.
82250 / Boss 6NSB313822501 —On the market

Similar devices

Other devices filed under FDA product code ITI (Wheelchair, Powered).

Other devices from Burke, Inc.

See all devices from Burke, Inc. →