Catalog Number

ElZ5A

Brand Name

Zippie® Series Manual Wheelchair

Version/Model Number

ElZ5A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2021

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

-

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

-

Product Code

IOR

Product Code Name

WHEELCHAIR, MECHANICAL

Public Device Record Key

8298d346-f5a0-4067-863d-999109e8bdc7

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-