FDA.reportPublic FDA data

Profile Applicator

Primary DI
00812265010300
Brand
Profile Applicator
Company
SANUWAVE Health, Inc.
Model
FLE0104
Device description
Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812265010300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812265010300008122650103008122650103000812265010300

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological extracorporeal shock wave therapy system applicatorA hand-held component of a dermatological extracorporeal shock wave therapy (ESWT) system designed to transmit spark-gap-generated (electrohydraulic) shock waves to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; traumatic wounds; cellulite). It is connected to the system generator by a flexible conduit and has a fluid-filled head portion intended to be moved over the skin surface of the treatment area for application of the shock waves. It is typically used with a sterile drape during treatment of open wounds and requires a sterile transmission media (ultrasonic gel). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
678-578-0108order@sanuwave.com

Regulatory Flags#

DUNS number
962510686
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812265010201dermaPACE ApplicatorDAP03322021-01-25
00812265010218dermaPACE ConsoleDEP03302021-01-25
00812265010225dermaPACE System (Console with applicator)DEP0330/DAP03322021-01-25
00812265010287Profile ConsolePRF1002021-01-25
00812265010294Profile Applicator FLE01032021-01-25
00812265010317UltraMIST GeneratorCP-800312021-01-25
00812265010324UltraMIST Treatment WandCP-800332021-01-25
00812265010331UltraMIST Single Use ApplicatorAS-550572021-01-25
00812265010348UltraMIST Single Use Applicator (12 Pack)CP-800402021-01-25

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