FDA 510(k) Application Details - K191334

Device Classification Name Wheelchair, Standup

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510(K) Number K191334
Device Name Wheelchair, Standup
Applicant MATIA Robotics (US) Inc
1929 S 4130 W, Unit A
Salt Lake City, UT 84104 US
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Contact Necati Hacikadiroglu
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Regulation Number 890.3900

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Classification Product Code IPL
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Date Received 05/17/2019
Decision Date 05/29/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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