Catalog Number

NXT-303xx

Brand Name

Freedom Designs® - NXT® Engineering Series

Version/Model Number

NXT_SERIES

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K023574

Product Code

IOR

Product Code Name

Wheelchair, mechanical

Public Device Record Key

6e377319-c23a-4c48-9dca-b0b928c9b052

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-