Iob Iob-029

• FDA 510(k) K190221 decided 25 Oct 2019 Active
• FDA GUDID UDI-DI 00850035767290 listed 8 Mar 2022 Listed

1. 25 Oct 2019 Cleared FDA 510(k) K190221
2. 8 Mar 2022 Listed FDA GUDID 00850035767290

Trade name

Iob

Generic name

Circulating-air whole-body heating system control unit

Model / reference

IOB-029

Primary DI / UDI-DI

00850035767290

510(k) Number

K190221 ↗

FDA product code

DWJ

GMDN term

Circulating-air whole-body heating system control unit

Device class

Class II

Regulation number

870.5900

GUDID distribution status

In Commercial Distribution

Category: Circulating-air whole-body heating system control unit

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

• CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 by Thermogear, Inc.
• Large Kool Kit® 930 82930 by Gentherm Medical LLC
• TC-1000, TC-1050 Thermal Regulating System by Gaymar Industries, Inc.
• ComfortTemp Patient Warming System by MEDLINE INDUSTRIES, INC.
• Temp Marq Convective Warming System by Marquest Medical Products, Inc.
• Arctic Sun® Temperature Management System, Temperature Cable Nellcor 73502 by Medivance, Inc.
• Geratherm SOS-Rescue Blanket by Rg Ent., Inc.
• MEDI-THERM by Gaymar Industries, Inc.
• Bair Hugger Torso Blanket – Arms In Model 540 by Augustine Medical, Inc.
• Kool Kit® 900 82900 by Gentherm Medical LLC

• 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. →