Catalog Number

-

Brand Name

Utopia Gear

Version/Model Number

Massage Pro 3.0

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141260,K141260

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

7dd5c822-583b-4a4a-8586-99274eeb2b47

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 27, 2016

Package DI Number

10862081000303

Quantity per Package

30

Contains DI Package

00862081000306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case