Catalog Number

5032

Brand Name

emFieldPro

Version/Model Number

5032

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182963

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

5a29aedd-0dd6-4614-ae69-83b6e584e0af

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

July 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-