THERMOTEK, INC.

Address:1200 LAKESIDE PKWY STE 200,Flower Mound,TX,75028,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) (3) Sleeve, Limb, Compressible (JOW) (3)

Premarket Exempt

No Yes

Clear

PT9 - B5850P9PT09SYS0 Catalog Number : 0P9PT09SYS

Device Description : PT9 Therapy System

Device Class : 2

Duns Number: 847899911

Premarket Exempt : Yes

Product Code : JOW, ILO

Prescription Use : Yes

Device Count : 1

VascuTherm4 - B5850P9PTVT4000 Catalog Number : 0P9PTVt400

Device Description : VascuTherm4 Therapy System

Device Class : 2

Duns Number: 847899911

Premarket Exempt : No

Product Code : JOW, ILO

Prescription Use : Yes

Device Count : 1

VascuTherm5 - B5850P9PTVT5000 Catalog Number : 0P9PTVT500

Device Description : VascuTherm5 Therapy System

Device Class : 2

Duns Number: 847899911

Premarket Exempt : No

Product Code : JOW, ILO

Prescription Use : Yes

Device Count : 1

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