Catalog Number

5511

Brand Name

Eclipse Bariatric Manual Wheelchair

Version/Model Number

ECLIPSE

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

K971389

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Public Device Record Key

58dc4408-be6e-45b2-b3c4-fdaa6b6f4402

Public Version Date

October 06, 2020

Public Version Number

1

DI Record Publish Date

September 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-