Catalog Number

SP3_30270XX, SPM_30270XX

Brand Name

Freedom Designs Spectrum 3 Series Manual Wheelchair

Version/Model Number

SP3_SERIES

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K952431

Product Code

IOR

Product Code Name

Wheelchair, mechanical

Public Device Record Key

df480dc3-e6c5-43c4-83a5-ae57822fd113

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-