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Pacesaver & Scout

by Burke, Inc.

510(k) K834506

Pacesaver & Scout is a medical device (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Burke, Inc., cleared under FDA 510(k) K834506 on 30 Jan 1984, 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 NumberK834506 Date30 Jan 1984ClearedStatusActive

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  • Withdrawn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
INI
Device class
Class II
Regulation
21 CFR Part 890.3800
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

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. →