FDA 510(k) Application Details - K251570

Device Classification Name Wheelchair, Special Grade

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510(K) Number K251570
Device Name Wheelchair, Special Grade
Applicant Vipamat Sarl
3 Rue Gustave Eiffel
Ploemeur 56270 FR
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Contact Vincent Leroy
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Regulation Number 890.3880

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Classification Product Code IQC
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Date Received 05/22/2025
Decision Date 06/23/2025
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 K251570


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