FDA 510(k) Application Details - K221438

Device Classification Name Wheelchair, Powered

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510(K) Number K221438
Device Name Wheelchair, Powered
Applicant Whill, Inc.
2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F
Shinagawa-ku 140-0002 JP
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Contact Tsuyoshi Iriyama
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 05/17/2022
Decision Date 06/07/2022
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 Y
Expedited Review



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