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) (7)

Premarket Exempt

Clear

Blue Boot - 00817369020309 Catalog Number : 20106

Device Description : 4 Cell Standard Blue Boot

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW, IRP

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020316 Catalog Number : 20107

Device Description : 5 Cell XL Zippered Blue Boot

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020323 Catalog Number : 20108

Device Description : 4 Cell XL Zippered Blue Boot

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW, IRP

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020330 Catalog Number : 20109

Device Description : 5 Cell Extra Long Boot Blue

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020347 Catalog Number : 20110

Device Description : 5 Cell XL Boot Blue

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW, IRP

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020354 Catalog Number : 20111

Device Description : 4 Cell XL Boot Blue

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP, JOW

Prescription Use : Yes

Device Count : 1

Blue Boot - 00817369020361 Catalog Number : 20112

Device Description : 3 Cell Zippered Boot Blue

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW, IRP

Prescription Use : Yes

Device Count : 1

Pulse Arm Sleeve - 00817369020378 Catalog Number : 20200

Device Description : Pulse Right Arm Sleeve Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Pulse Arm Sleeve - 00817369020385 Catalog Number : 20201

Device Description : Pulse Left Arm Sleeve Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Right Arm Sleeve Black - 00817369020392 Catalog Number : 20203

Device Description : Right Arm Sleeve Black

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

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