Catalog Number

USFPC1

Brand Name

Ultratone

Version/Model Number

Futura Pro (US Specification)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

IMG

Product Code Name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Public Device Record Key

31fe3727-752c-4519-9f18-62880b146221

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-