IOB Warming Blankets

510(k) Number

K190221 ↗

FDA product code

DWJ

Device class

Class II

Regulation

21 CFR Part 870.5900

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DWJ (System, Thermal Regulating).

• PINTLER PATIENT WARMING SYSTEM by Pintler Medical
• INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 by Inditherm Medical
• HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) by Http Hypothermia Therapy
• Altrix Temperature Management Wraps by Stryker Medical
• Maxi-Therm® Lite Headwrap 600 82600 by Gentherm Medical LLC
• CONTOR TABLE SURFACE by HILL-ROM, INC.
• HotDog Warming Mattress + Return Electrode by Augustine Temperature Management, LLC
• ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 by Medivance, Inc.
• Arctic Sun® Temperature Management System, Temperature Simulator 77700 by Medivance, Inc.
• MAXITHERM by Cincinnati Sub-Zero

• IOB Warming Blankets

  Class II

  FDA 510(k) K221669 Active Cleared 27 Dec 2022

• Iob Iob-006

  Class II

  FDA 510(k) K162679 Active Cleared 28 Apr 2017 GUDID on market

• Iob Iob-016

  Class II

  FDA 510(k) K162679 Active Cleared 28 Apr 2017 GUDID on market

• Iob Iob-304

  Class II

  FDA 510(k) K190221 Active Cleared 25 Oct 2019 GUDID on market

See all devices from Iob Medical, Inc. →