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

Clear

Therm-X - 00850001096157 Catalog Number : TX0207

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096164 Catalog Number : TX0208

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096171 Catalog Number : TX0108

Device Description : Therm-X Hip Garment

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096188 Catalog Number : TX0300

Device Description : Therm-X HOME

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096195 Catalog Number : TX0301

Device Description : Therm-X Shoulder SPU

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : IRP, JOW, ILO

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096201 Catalog Number : TX0302

Device Description : Therm-X Knee SPU

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096218 Catalog Number : TX0304

Device Description : Therm-X Ankle SPU

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096225 Catalog Number : TX0308

Device Description : Therm-X Hip SPU

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096232 Catalog Number : TX0305

Device Description : Therm-X Back SPU

Device Class : 2

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

Therm-X - 00850001096256 Catalog Number : TX0107

Device Description : Therm-X Disposable Calf DVT Garment

Device Class :

Duns Number: 062931546

Premarket Exempt : No

Product Code : JOW, ILO, IRP

Prescription Use : Yes

Device Count : 1

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