Catalog Number

MA2RW10

Brand Name

geko

Version/Model Number

A-2

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"

Yes

For Single-Use

Yes

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

K193045

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

df9871f7-209c-4e64-8a7c-209fa25de8c8

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-