INNOVATIVE MEDICAL EQUIPMENT, LLC

Address:23950 Commerce Park,Beachwood,OH,44122,US

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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

Pack, Hot Or Cold, Water Circulating (ILO) (9) Stand, Infusion (FOX) (1)

Premarket Exempt

Yes

Clear

ThermaZone - 00854682001356 Catalog Number : 003-99

Device Description : ThermaZone Thermal Therapy Device with medical grade power supply

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001486 Catalog Number : 003-27

Device Description : ThermaZone Single Patient Use Knee Pad.

Device Class :

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001493 Catalog Number : 003-28

Device Description : ThermaZone Single Patient Use Back Pad.

Device Class :

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001509 Catalog Number : 003-29

Device Description : ThermaZone Single Patient Use Ankle Pad.

Device Class :

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001523 Catalog Number : 003-26

Device Description : ThermaZone Single Patient Use Hip Pad.

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001547 Catalog Number : 003-79

Device Description : ThermaZone Hospital Bed Bracket. This device can attach directly to the patient' ThermaZone Hospital Bed Bracket. This device can attach directly to the patient's bed or to the ThermaZone IV pole with base.

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

ThermaZone - 00854682001554 Catalog Number : 003-43

Device Description : ThermaZone IV Pole with basket (Ships in three cartons).

Device Class : 1

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : No

Device Count : 1

ThermaZone - 00854682001561 Catalog Number : 003-35

Device Description : ThermaZone Standard Power Supply Assembly.

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001578 Catalog Number : 003-07

Device Description : ThermaZone Thermal Therapy Device with standard power supply

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

ThermaZone - 00854682001615 Catalog Number : 003-08

Device Description : ThermaZone Thermal Therapy Device with medical grade power supply.

Device Class : 2

Duns Number: 833969186

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

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