FDA 510(k) Application Details - K170507

Device Classification Name Wheelchair, Powered

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510(K) Number K170507
Device Name Wheelchair, Powered
Applicant Invacare Corporation
One Invacare Way
Elyria, OH 44035 US
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Contact Elijah N. Wreh
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/21/2017
Decision Date 07/12/2017
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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