DEVICE: Scout (B314831731)

Device Identifier (DI) Information

Scout
RF-P4 W/S
In Commercial Distribution
83173
BURKE, INC.
B314831731
HIBCC

1
045093101 *Terms of Use
Power Wheelchair
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsible A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device cannot be folded or readily dismantled for transport.
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FDA Product Code

[?]
Product Code Product Code Name
ITI Wheelchair, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982158 000
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Sterilization

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

[?]
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

8b7a78dc-912d-4013-8e7f-0453421ef2d3
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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