Vail 3000 Bed Enclosure

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963589 ↗

FDA Product Code

FNL

Device Class

Class II

Regulation

21 CFR Part 880.5100

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vail 1000 Enclosed Bed

  Class II

  FDA 510(k) K982783 Active Cleared 5 Oct 1998

• Vail 2000 Enclosed Bed

  Class II

  FDA 510(k) K963622 Active Cleared 7 May 1997

• Vail 100 Pediatric Crib

  Class II

  FDA 510(k) K963210 Active Cleared 13 Nov 1996

• What clinical setting is the Vail 3000 Bed Enclosure intended for?

  It is designed for hospital use, providing an adjustable surface that allows patients to change height and contour, which supports positioning, comfort, and care activities in an inpatient environment.

• How is the Vail 3000 Bed Enclosure supplied to the purchaser?

  The device is delivered as a complete bed system, meaning the frame, motorized adjustments, remote controls, and side rails are all included together, so no additional components need to be sourced separately.

• What safety features are built into the Vail 3000 Bed Enclosure?

  The enclosure includes movable, latchable side rails that can be secured to prevent patient falls, and the electric motor provides controlled adjustments to avoid abrupt movements, enhancing patient safety during repositioning.

• Is the Vail 3000 Bed Enclosure a single‑use product or reusable?

  It is a reusable, durable hospital bed intended for repeated use across many patients; the AC‑powered motor and rail system are built for long‑term service rather than disposable application.

• What regulatory clearance does the Vail 3000 Bed Enclosure have?

  The device received FDA 510(k) clearance (K963589) on April 21, 1997, classified as a Class II product under code FNL with special controls, indicating it was found substantially equivalent to a legally marketed predicate.