Catalog Number

-

Brand Name

BREEZ CHAIR

Version/Model Number

1025-G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K111095

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

c50e41e8-a96c-48a5-8792-da5cb4a69c21

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-