NORMATEC INDUSTRIES LP

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

Sleeve, Limb, Compressible (JOW) (7) Massager, Powered Inflatable Tube (IRP) (3)

Premarket Exempt

No

Clear

NormaTec Pulse - 00817369020002 Catalog Number : 10100

Device Description : NormaTec Pulse Control Unit

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

NormaTec Pulse Pro - 00817369020019 Catalog Number : 10200

Device Description : NormaTec Pulse Pro Control Unit

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

NormaTec MVP - 00817369020026 Catalog Number : 10500

Device Description : NormaTec MVP Control Unit

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

NormaTec MVP Pro - 00817369020033 Catalog Number : 10600

Device Description : NormaTec MVP Pro

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

NormaTec MVP Pro - 00817369020040 Catalog Number : 10601

Device Description : NormaTec MVP Pro w/CPC conn., not lighted

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

NormaTec MVP Pro - 00817369020057 Catalog Number : 10602

Device Description : NormaTec MVP Pro w/NT conn., not lighted

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

NormaTec MVP Pro - 00817369020064 Catalog Number : 10603

Device Description : NormaTec MVP Pro w/NT conn., lighted, 220v

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

NormaTec MVP Pro - 00817369020071 Catalog Number : 10604

Device Description : NormaTec MVP Pro w/CPC conn., lighted

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Via - 00817369020088 Catalog Number : 10700

Device Description : NormaTec Via

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Via Elite - 00817369020095 Catalog Number : 10800

Device Description : NormaTec Via Elite

Device Class : 2

Duns Number: 111448069

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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