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IMD — Pack, Hot Or Cold, Disposable Class I

FDA Device Classification

Classification Details

Product Code
IMD
Device Class
Class I
Regulation Number
890.5710
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221653international biomedicalInfaTherm Disposable Infant Warming MattressOctober 6, 2022
K163295rapid aidInfant Transport Mattress Warmer with DiscJuly 24, 2017
K112547denovo prouctsNEO NESTMarch 6, 2012
K082087bio-lipidEYEFEEL OPHTHALMIC WARMERSeptember 11, 2008
K071710johnson and johnson consumer productsBENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)August 14, 2007
K021843bio-lipidEYEFEEL OPHTHALMIC WARMERSeptember 3, 2002
K982652allegiance healthcareALLEGIANCE PORTA-WARM MATTRESSJanuary 21, 1999
K980509deroyal industriesDEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESSFebruary 26, 1998
K974190consolidated products and servicesCP&S INSTANT COLD PACK LIMB KIT TRANSPORTERNovember 19, 1997
K973770allegiance healthcareALLEGIANCE KWIK HEAT WARM PERINEAL PACKNovember 13, 1997
K970399allegiance healthcareKWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)April 3, 1997
K963689florida medical industriesRECOVER ADULT VEIN WARMERDecember 12, 1996
K963768kick iceINSTANT HOT PACKSNovember 25, 1996
K963666kick iceINSTANT COLD PACKOctober 30, 1996
K963220tempo technologyTEMPRA COLD PACK, REORDER NO. TC150October 10, 1996
K961176omni thermOMNI COLD GEL PACKSSeptember 4, 1996
K955788omni thermIMNI HOT PACKSSeptember 4, 1996
K951033candela laserANDELA DYNAMIC COOLING DEVICEAugust 15, 1996
K960624certified safety mfgCERTI COOL INSTANT COLD COMPRESSMay 6, 1996
K954877omni thermOMNI COLD GEL PACKSFebruary 13, 1996