Life-Air 1000 Patient Warming Cover

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

510(k) Number

K933764 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Luminous 250 Fiberoptic Illuminator

  Class II

  FDA 510(k) K921866 Active Cleared 8 Jul 1992

• Life-Air 1000 Hypothermic Treatment System

  Class II

  FDA 510(k) K914382 Active Cleared 21 Apr 1992

• Luminous 150 Dual Lampfiberoptic Illuminator

  Class II

  FDA 510(k) K944688 Active Cleared 1 Nov 1994

• Life-Air 1000 Patient Warming Covers

  Class II

  FDA 510(k) K914383 Active Cleared 30 Mar 1992

• Life-Air 1000 Hypothermic Therapy System

  Class II

  FDA 510(k) K952329 Active Cleared 17 Jan 1996

• Luminous 150 Fiberoptic Illuminator

  Class II

  FDA 510(k) K933593 Active Cleared 28 Oct 1993

• What is the Life-Air 1000 Patient Warming Cover used for?

  The Life-Air 1000 Patient Warming Cover is a disposable device designed to reduce the effects of hypothermia during and after surgery by providing patient warming in both operating and recovery rooms when used with the Life-Air 1000 Hypothermic Therapy System.

• Is the warming cover single-use or reusable?

  The warming cover is a single-use device, meaning it should be discarded after one patient use to maintain hygiene and ensure proper functioning as part of the thermal regulating system.

• What models are available for the Life-Air 1000 Patient Warming Cover?

  The warming cover is available in several specially designed models for different applications, though specific model details are not provided in the device data.

• What is the regulatory classification of this device?

  The Life-Air 1000 Patient Warming Cover has received FDA 510(k) clearance with product code DWJ and is classified as a Class II medical device, indicating it has moderate risk controls.