Catalog Number

-

Brand Name

XFT

Version/Model Number

XFT-2001D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K162718

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Public Device Record Key

0f3794cc-4d1e-4e64-8a41-ab8b8bae28fa

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

January 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-