NORMATEC INDUSTRIES LP

Address:480 Pleasant Street, Suite A200,Watertown,MA,02472,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) Sleeve, Limb, Compressible (JOW) (4)

Premarket Exempt

Clear

Pulse Boot - 00817369020101 Catalog Number : 20000

Device Description : Pulse Standard Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Boot - 00817369020118 Catalog Number : 20001

Device Description : Pulse Tall Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Boot - 00817369020125 Catalog Number : 20002

Device Description : Pulse Short Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Boot - 00817369020132 Catalog Number : 20003

Device Description : Pulse Power Short Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Boot - 00817369020149 Catalog Number : 20004

Device Description : Pulse Power Standard Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Boot - 00817369020156 Catalog Number : 20005

Device Description : Pulse Power Tall Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Black Boot - 00817369020163 Catalog Number : 20006

Device Description : 5 Cell Extra Long Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Black Boot - 00817369020170 Catalog Number : 20007

Device Description : 5 Cell Standard Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Black Boot - 00817369020187 Catalog Number : 20008

Device Description : Standard Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Black Boot - 00817369020194 Catalog Number : 20009

Device Description : Tall Zippered Boot Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

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