Cool/Heat Therapy Applicator

FDA 510(k) K944447 · Medical Science Technology, Inc.

Substantially Equivalent for Some Indications

510(k) numberK944447

Submission

Device name
Cool/Heat Therapy Applicator
Applicant
Medical Science Technology, Inc.
Fredericksburg, VA, US
Received
September 12, 1994
Decision date
February 9, 1995
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ILO – Pack, Hot Or Cold, Water Circulating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5720
Specialty
Physical Medicine

Other 510(k)s with product code ILO

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K213097Armory MotionILO · Traditional Pain Management Technologies, Inc.06/10/2022SE
K083008CoolskinILO · Abbreviated Elbio Co., Ltd.06/10/2009SE
K073675T-Pump Localized Temperature Therapy PumpILO · Traditional Gaymar Industries, Inc.05/08/2008SE
K072152Juniper CLN1 Dermal Cooling DeviceILO · Traditional Juniper Medical, Inc.09/07/2007SE
K070402Modification to Polar Care 500ILO · Special Breg, Inc.03/29/2007SE
K040317Ivc SystemILO · Traditional Mark H. Friedman05/07/2004SE
K973023Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional Hollister, Inc.11/03/1997SE
K970197HTP-1500 Localized Heat Therapy PumpILO · Traditional Adroit Medical Systems, Inc.09/10/1997SE
K964799Artrotherm Cryotherapy and ThernotherapyILO · Traditional Ormed GmbH08/29/1997SE
K964354Artocool-S Water Circulating Cold PackILO · Traditional Ormed GmbH08/29/1997SE

Questions and answers

When was Cool/Heat Therapy Applicator cleared by the FDA?

Cool/Heat Therapy Applicator (K944447) received a 510(k) decision of Substantially Equivalent for Some Indications on February 9, 1995, 150 days after the submission was received.

What is the product code of K944447?

The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.