Turbo II

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

510(k) Number

K933402 ↗

FDA Product Code

FNM

Device Class

Class II

Regulation

21 CFR Part 880.5550

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cowboy II

  Class II

  FDA 510(k) K920308 Active Cleared 24 Aug 1992

• Kinair, Low Air Loss Bed

  Class II

  FDA 510(k) K843781 Active Cleared 28 Jan 1985

• Vacplus

  Class II

  FDA 510(k) K945062 Active Cleared 14 Mar 1995

• Modified Pedikair

  Class II

  FDA 510(k) K954320 Active Cleared 18 Jul 1997

• Glenn Bed

  Class II

  FDA 510(k) K931581 Active Cleared 21 Oct 1993

• Premium

  Class II

  FDA 510(k) K930673 Active Cleared 2 Aug 1993

See all devices from Kinetic Concepts, Inc. →

• What is the Turbo II Air Flotation Mattress designed for?

  The Turbo II is specifically designed to provide pressure redistribution and support for patients at risk of developing pressure ulcers or requiring off-loading therapy. It uses alternating air cells to cycle pressure, reducing sustained pressure points and promoting circulation in immobilized or bedridden individuals, particularly in general hospital settings.

• How is the Turbo II supplied and what are its sterility and reuse characteristics?

  The Turbo II is supplied as a reusable mattress and is non-sterile. This means it is intended for repeated use in clinical environments after proper cleaning and maintenance, as outlined in the manufacturer’s documentation, rather than being single-use or sterile.

• What sizes are available for the Turbo II?

  The Turbo II is available in standard sizes, though the exact dimensions are not specified in the provided data. The regulatory filings reference multiple FEI numbers, indicating various models or configurations may exist, but specific measurements would require consulting the manufacturer’s documentation or product catalog.

• Can the Turbo II be used with MRI equipment?

  No, the Turbo II is not MRI-compatible. This means it should not be used in MRI environments, as the alternating air cells could interfere with MRI imaging or pose safety risks during the procedure.

• What regulatory pathway was followed for the Turbo II’s clearance?

  The Turbo II was cleared through the FDA’s Traditional 510(k) pathway, specifically under the classification of a Class II device (FDA regulation 880.5550). This pathway demonstrates that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use.