Catalog Number

-

Brand Name

ParaGolfer

Version/Model Number

490E54=00000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2020

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

K060936

Product Code

IPL

Product Code Name

Wheelchair, Standup

Public Device Record Key

7df2c0ce-5b16-4863-b8f0-6afd72ba138b

Public Version Date

September 16, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-