Catalog Number

-

Brand Name

No

Version/Model Number

FM-B2409

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

K202866,K202866

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

9caa0673-41df-4eb2-8c04-3cf414dc2035

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

16973810850091

Quantity per Package

60

Contains DI Package

06973810850094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

paper