Omni Cold Gel Packs

FDA 510(k) K961176 · Omni Therm, Inc.

Substantially Equivalent

510(k) numberK961176

Submission

Device name
Omni Cold Gel Packs
Applicant
Omni Therm, Inc.
St. Louis, MO, US
Received
March 25, 1996
Decision date
September 4, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IMD – Pack, Hot Or Cold, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 890.5710
Specialty
Physical Medicine

Other 510(k)s with product code IMD

510(k)DeviceApplicantDecision
K221653InfaTherm Disposable Infant Warming MattressIMD · Traditional International Biomedical10/06/2022SE
K163295Infant Transport Mattress Warmer with DiscIMD · Traditional Rapid Aid Corp.07/24/2017SE
K112547Neo NestIMD · Traditional Denovo Proucts, LLC03/06/2012SE
K082087Eyefeel Ophthalmic WarmerIMD · Traditional Bio-Lipid, Inc.09/11/2008SE
K071710Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)IMD · Traditional Johnson & Johnson Consumer Products, Inc.08/14/2007SE
K021843Eyefeel Ophthalmic WarmerIMD · Traditional Bio-Lipid, Inc.09/03/2002SE
K982652Allegiance Porta-Warm MattressIMD · Traditional Allegiance Healthcare Corp.01/21/1999SE
K980509Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional Deroyal Industries, Inc.02/26/1998SE
K974190Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional Consolidated Products & Services, Inc.11/19/1997SE
K973770Allegiance Kwik Heat Warm Perineal PackIMD · Traditional Allegiance Healthcare Corp.11/13/1997SE

More from Allegiance Healthcare Corp.

510(k)DeviceDecision
K955788Imni Hot PacksIMD · Traditional 09/04/1996SE
K954877Omni Cold Gel PacksIMD · Traditional 02/13/1996SN
K936084Omni Warm Gel PacksIMD · Traditional 03/31/1994SE
K864853Omni Therm Temperature MonitorKPD · Traditional 02/04/1987SE

Questions and answers

When was Omni Cold Gel Packs cleared by the FDA?

Omni Cold Gel Packs (K961176) received a 510(k) decision of Substantially Equivalent on September 4, 1996, 163 days after the submission was received.

What is the product code of K961176?

The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.