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Burke Bari-Float Mattress 54"

by Burke, Inc.

Burke Bari-Float Mattress 54" (63410) is an assistive scooter (FDA Class I; FDA product code IKY, Mattress, Flotation Therapy, Non-Powered) made by Burke, Inc., listed in FDA GUDID since 1 Sep 2016 (UDI-DI B314634101), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB314634101 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Burke
Generic name
Assistive scooter, electric-motor-driven
Model / Ref / Catalog
Bari-Float Mattress 54", 63410
Primary DI / UDI-DI
B314634101
FDA product code
IKY
GMDN term
Assistive scooter, electric-motor-driven
Device class
Class I
Regulation number
880.5150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assistive scooter, electric-motor-driven

Similar devices

Other devices filed under FDA product code IKY (Mattress, Flotation Therapy, Non-Powered).

Other devices from Burke, Inc.

See all devices from Burke, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)