Profile Console - Profile provides mechanically assisted deep soft - Sanuwave, Inc.

Duns Number:832217439

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

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More Product Details

Catalog Number

-

Brand Name

Profile Console

Version/Model Number

PRF100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ISA

Product Code Name

Massager, Therapeutic, Electric

Device Record Status

Public Device Record Key

ff5aa378-314a-480f-978b-ba0b7c929c3a

Public Version Date

February 02, 2021

Public Version Number

1

DI Record Publish Date

January 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SANUWAVE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 7