Instant Warm Gel Pack

FDA 510(k) K912715 · Prism Technologies, Inc.

Substantially Equivalent

510(k) numberK912715

Submission

Device name
Instant Warm Gel Pack
Applicant
Prism Technologies, Inc.
Chicago, IL, US
Received
June 18, 1991
Decision date
October 2, 1991
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

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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
K980212MityvacHDB · Traditional 07/09/1998SE
K953542ColdgelIMD · Traditional 10/30/1995SN
K953541Instant ColdgelIMD · Traditional 10/05/1995SE
K934631TranswarmerIMD · Traditional 02/03/1994SE

Questions and answers

When was Instant Warm Gel Pack cleared by the FDA?

Instant Warm Gel Pack (K912715) received a 510(k) decision of Substantially Equivalent on October 2, 1991, 106 days after the submission was received.

What is the product code of K912715?

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