Sanuwave, Inc.

Address:11495 Valley View Road,Eden Prairie,MN,55344,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

Wound Cleaner, Ultrasound (NRB) (4) Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers (PZL) (3) Massager, Therapeutic, Electric (ISA) (3)

Premarket Exempt

No Yes

Clear

dermaPACE Applicator - 00812265010201 Catalog Number :

Device Description : Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPAC Delivery device of Extracorporeal Shock Wave (ESW), an accessory to the dermaPACE, for the treatment of diabetic foot uclers

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : PZL

Prescription Use : No

Device Count : 1

dermaPACE Console - 00812265010218 Catalog Number :

Device Description : Energy generator and control unit ( t be used in conjuction with the PACE Applic Energy generator and control unit ( t be used in conjuction with the PACE Applicator) for the delivery of Extracorporeal Shock Waves (ESW) for the treatment of Diabetic Foot Ulcers.

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : PZL

Prescription Use : No

Device Count : 1

dermaPACE System (Console with applicator) - 00812265010225 Catalog Number :

Device Description : The dermaPACE console and applicator shipped together. An assembly of devices de The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : PZL

Prescription Use : No

Device Count : 1

Profile Console - 00812265010287 Catalog Number :

Device Description : Profile provides mechanically assisted deep soft tissue massage through a novel Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure.

Device Class : 1

Duns Number: 832217439

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Profile Applicator - 00812265010294 Catalog Number :

Device Description : Profile Hand-held Treatment Applicator designed to use with Profile Control Cons Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)

Device Class : 1

Duns Number: 832217439

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Profile Applicator - 00812265010300 Catalog Number :

Device Description : Profile Hand-held Treatment Applicator designed to use with Profile Control Cons Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)

Device Class : 1

Duns Number: 832217439

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

UltraMIST Generator - 00812265010317 Catalog Number :

Device Description : The UltraMIST Generator

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : NRB

Prescription Use : No

Device Count : 1

UltraMIST Treatment Wand - 00812265010324 Catalog Number :

Device Description : Component to the UltraMIST System

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : NRB

Prescription Use : No

Device Count : 1

UltraMIST Single Use Applicator - 00812265010331 Catalog Number :

Device Description : Applicator fr UltraMIST (Wound Cleanser)

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : NRB

Prescription Use : No

Device Count : 1

UltraMIST Single Use Applicator (12 Pack) - 00812265010348 Catalog Number :

Device Description : UltraMIST Single Use Applicator (12 pack Carton) Wound Cleanser

Device Class : 2

Duns Number: 832217439

Premarket Exempt : No

Product Code : NRB

Prescription Use : No

Device Count : 1

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