Catalog Number

atpr

Brand Name

Amysystems

Version/Model Number

atpr

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 17, 2017

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

K092225

Product Code

ITI

Product Code Name

Wheelchair, Powered

Public Device Record Key

7d6b0bf7-1fdd-427e-85d7-81e5885090f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-