Catalog Number

-

Brand Name

Karma

Version/Model Number

KM-2501

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062309

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Public Device Record Key

2e9bc0a1-2dc1-4039-9127-8912346e6ce5

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-