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Iob Iob-028

by Iob Medical, Inc.

Iob Iob-028 is a Class II device made by Iob Medical, Inc., cleared under FDA 510(k) K190221 on 25 Oct 2019 and listed in FDA GUDID since 8 Mar 2022 (UDI-DI 00850035767283), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K190221

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850035767283 UDI-DI Date8 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190221 Date25 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190221 decided 25 Oct 2019 Active
  • FDA GUDID UDI-DI 00850035767283 listed 8 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190221
  2. Listed FDA GUDID 00850035767283

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Iob
Generic name
Circulating-air whole-body heating system control unit
Model / reference
IOB-028
Primary DI / UDI-DI
00850035767283
510(k) Number
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

Related devices

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

Cleared under the same submission (K190221)

and 8 more cleared under K190221

Similar devices

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

Other devices from Iob Medical, Inc.

  • IOB Warming Blankets

    Class II

  • Iob Iob-006

    Class II

  • Iob Iob-016

    Class II

  • Iob Iob-304

    Class II

See all devices from Iob Medical, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)