ZENITH TECHNICAL INNOVATIONS, LLC

ZENITH TECHNICAL INNOVATIONS, LLC

Address:1396 SAINT PAUL AVE,Gurnee,IL,60031,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

Massager, Powered Inflatable Tube (IRP) (10) Pack, Hot Or Cold, Water Circulating (ILO) (10) Sleeve, Limb, Compressible (JOW) (10)

Premarket Exempt

No

Clear

Therm-X - 00850001096003 Catalog Number : TX0001

Device Description : Therm-X Pro

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096010 Catalog Number : TX0002

Device Description : Therm-X AT

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096027 Catalog Number : TX0105

Device Description : Therm-X Back Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096034 Catalog Number : TX0102

Device Description : Therm-X Knee Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096041 Catalog Number : TX0104

Device Description : Therm-X Ankle Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096058 Catalog Number : TX0103

Device Description : Therm-X Elbow Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096065 Catalog Number : TX0101

Device Description : Therm-X Shoulder Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096072 Catalog Number : TX0107

Device Description : Therm-X Calf DVT Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096089 Catalog Number : TX0106

Device Description : Therm-X Foot DVT Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096096 Catalog Number : TX0201

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

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