Catalog Number

5527

Brand Name

Bentley Manual Tilt Wheelchair

Version/Model Number

BENTLEY LT-R

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

K970311

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Public Device Record Key

50bff51f-a522-4242-9f99-8c2e195ae8da

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-