FDA 510(k) Application Details - K171256

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K171256
Device Name Vehicle, Motorized 3-Wheeled
Applicant Agile Distributors LLC
2283 East Zion Way
Chandler, AZ 85249 US
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Contact Steven Mahaffy
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 04/28/2017
Decision Date 06/08/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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