Everest & Jennings - Advantage LX Wheelchair - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: Advantage LX Wheelchair

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More Product Details

Catalog Number

-

Brand Name

Everest & Jennings

Version/Model Number

3H021110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K052468

Product Code Details

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

5a8b5dcf-e332-43c2-955e-61a06c5136b8

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202