KAZ USA, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pad, Heating, Powered (IRT) (9) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

SoftHeat - 00328785000122 Catalog Number : HP218V1

Device Description : Electric Heat Pad, MaxHeat by Softheat, 24" x 12", 3 heat settings, 60 minute au

Device Class : 2

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Braun - 00328785000146 Catalog Number :

Device Description : Thermometer, Braun Compact Ear, Audio Fever Indicator w/21 Lens Filters.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

SoftHeat - 00328785000153 Catalog Number : HP750V1

Device Description : Electric Heat Pad, MaxHeat by Softheat, 12" x 15", 4 heat settings, 60 minute au

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Softheat - 00328785000160 Catalog Number :

Device Description : ELECTRIC, MaxHeat by SoftHeat, 5yr, King, Smartwire

Device Class : 2

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

SoftHeat - 00328785000177 Catalog Number : HP950V1

Device Description : Electric Heat Pad, MaxHeat by Softheat, 12" x 24", 4 heat settings, 60 minute au

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

SoftHeat - 00328785000184 Catalog Number :

Device Description : Electric Heat Pad, MaxHeat by SoftHeat, 12" x 24", 4 heat settings, 60 minute au

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

SoftHeat - 00328785000191 Catalog Number :

Device Description : Electric Heat Pad, MaxHeat by SoftHeat, 4 heat settings, 10" x 22", moist even h

Device Class : 2

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Meijer - 00328785000207 Catalog Number :

Device Description : Electric Heat Pad, 12" x 15", 3 heat settings, 60 minute auto shut-off, moist or

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Meijer - 00328785000214 Catalog Number :

Device Description : Electric Heat Pad, 12" x 24", 3 heat settings, 60 minute auto shut-off, moist or

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Mind+Body Care - 00328785000238 Catalog Number :

Device Description : Mind+Body Care Spa WrapAround Pain relief for the Entire Body, 24" X 54”, 2 Hour

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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