FDA 510(k) Application Details - K010941

Device Classification Name Wheelchair, Powered

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510(K) Number K010941
Device Name Wheelchair, Powered
Applicant NIMBLE, INC.
55 NORTHERN BLVD.
SUITE 200
GREAT NECK, NY 10121 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 03/29/2001
Decision Date 06/22/2001
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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