FDA.reportPublic FDA data

Profile Console

Primary DI
00812265010287
Brand
Profile Console
Company
SANUWAVE Health, Inc.
Model
PRF100
Device description
Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure.
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
00812265010287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812265010287008122650102878122650102870812265010287

GMDN Terms#

Term, Definition table
TermDefinition
Spark-gap orthopaedic extracorporeal shock wave therapy systemA mobile assembly of devices designed to provide spark-gap-generated orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a generator with two submerged electrodes that produce spark-gap (electrohydraulic) energy, at selected impulse frequencies, transmitted in reflector-focused waves to a target area on the patient's body surface via a water-filled membrane (e.g., latex) held against the target area during treatment. It is used to treat disorders such as patellar tendonitis, soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), and/or non-union fractures of bones.

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
00812265010294Profile Applicator FLE01032021-01-25
00812265010300Profile Applicator FLE01042021-01-25
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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