Catalog Number

-

Brand Name

Utopia Gear

Version/Model Number

Pro 4.0

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

K143268,K143268

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

8cbcfc41-3a72-4bcd-badc-7ecc43c4d71b

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

00862081000375

Quantity per Package

36

Contains DI Package

00862081000368

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE