DEVICE: Go Go Ultra X 3 Wheel (00606509300223)

Device Identifier (DI) Information

Go Go Ultra X 3 Wheel
SC40X/S40X/Beaufort 3
In Commercial Distribution
N/A
PRIDE MOBILITY PRODUCTS CORPORATION
00606509300223
GS1

1
041477449 *Terms of Use
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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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
No
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Yes
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Assistive scooter, electric-motor-driven A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. The device is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.
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FDA Product Code

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Product Code Product Code Name
INI Vehicle, Motorized 3-Wheeled
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

017ded7b-9e3b-4347-bf93-9cffe8af71b4
March 29, 2018
2
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Customer Contact

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No Customer Contact currently defined
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