510(k) K933764

LIFE-AIR 1000 PATIENT WARMING COVER by Progressive Dynamics, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 9, 1993
Date Received: July 22, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Thermal Regulating
Device Class: Class II
Regulation Number: 870.5900
Review Panel: CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Progressive Dynamics, Inc.

K952329 — LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (January 17, 1996)
K944688 — LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (November 1, 1994)
K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
K921866 — LUMINOUS 250 FIBEROPTIC ILLUMINATOR (July 8, 1992)
K914382 — LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (April 21, 1992)
K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

Other clearances for product code DWJ

K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
K242964 — Celsi Warmer (June 20, 2025)
K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
K232638 — FilteredFlo Warming Blankets (October 24, 2023)
K232844 — The IQoolTM System (October 4, 2023)
K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
K231596 — IOB Temperature Management System (June 30, 2023)