FDA 510(k) Application Details - K240105

Device Classification Name Wheelchair, Powered

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510(K) Number K240105
Device Name Wheelchair, Powered
Applicant Forcemech International LLC
4111 Rice Drier Road #1H
Pearland, TX 77581 US
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Contact David Ou
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/16/2024
Decision Date 08/29/2024
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

FDA Source Information for K240105


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