WHEELCHAIR GLOVE - A special cover worn on the hands of a wheelchair - PRIDE MOBILITY PRODUCTS CORPORATION

Duns Number:041477449

Device Description: A special cover worn on the hands of a wheelchair occupant designed to protect their hands A special cover worn on the hands of a wheelchair occupant designed to protect their hands when propelling wheels that are equipped with rims; this may also apply to wheelchairs that are fully- or partially-powered. The cover may be designed for different activities. This is a reusable device.

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More Product Details

Catalog Number

N/A

Brand Name

WHEELCHAIR GLOVE

Version/Model Number

WHEELCHAIR GLOVE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KNO

Product Code Name

Accessories, Wheelchair

Device Record Status

Public Device Record Key

6e5746b5-9074-45e5-aec7-b122cffd7752

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIDE MOBILITY PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 296