Catalog Number

-

Brand Name

Electric wheelchair

Version/Model Number

W3421

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

K070501,K070501

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

8025ad2e-9ce3-4a7f-9afa-dab25fa35aff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 31, 2016

Package DI Number

06970765970051

Quantity per Package

1

Contains DI Package

06970765970020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-