DEVICE: Pacesave (B314150901)

Device Identifier (DI) Information

Pacesave
Fusion 500
In Commercial Distribution
15090
BURKE, INC.
B314150901
HIBCC

1
045093101 *Terms of Use
3 wheeled scooter
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Device Characteristics

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

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 [?]
K061912 000
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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

991625e1-4026-4ba8-927d-10520a682490
July 06, 2018
3
September 01, 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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
913-722-5658
jernst@burke-mobility.com
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