FDA 510(k) Application Details - K240120

Device Classification Name Wheelchair, Mechanical

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510(K) Number K240120
Device Name Wheelchair, Mechanical
Applicant Turbo Wheelchair Co., Inc.
247 America Place
Jeffersonville, IN 47130 US
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Contact Jane Hermes
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 01/16/2024
Decision Date 07/05/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240120


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