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510(k) K203085

NOVA Patient Warming System by Encompass Group, LLC — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2020
Date Received
October 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Encompass Group, LLC

  • K982058 — ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN (January 14, 1999)
  • K982059 — ROTECNO 2000 SURGICAL GOWN (November 30, 1998)
  • K760618 — PATIENT RESTRAINT (November 24, 1976)

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)