Catalog Number

T3US02

Brand Name

geko

Version/Model Number

T-3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K181059

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

fce8e9d7-f00c-4248-a7f8-a54ab75998b7

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

June 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-