Revo 2.0 4 Wheel - A motorized three-wheeled vehicle is a - PRIDE MOBILITY PRODUCTS CORPORATION

Duns Number:041477449

Device Description: A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

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More Product Details

Catalog Number

N/A

Brand Name

Revo 2.0 4 Wheel

Version/Model Number

S67

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"

Yes

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

INI

Product Code Name

Vehicle, Motorized 3-Wheeled

Device Record Status

Public Device Record Key

18bc7806-77fc-448f-be94-13f6d56a55da

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 2017

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