FDA 510(k) Application Details - K102734

Device Classification Name Wheelchair, Standup

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510(K) Number K102734
Device Name Wheelchair, Standup
Applicant COMFORT ORTHOPEDIC CO. LTD.
2064 TAMARIN DRIVE
COLUMBUS, OH 43235 US
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Contact JEN KE-MIN
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Regulation Number 890.3900

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Classification Product Code IPL
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Date Received 09/22/2010
Decision Date 12/14/2010
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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