FDA 510(k) Application Details - K023000

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K023000
Device Name Stimulator, Muscle, Powered
Applicant HOME CARE TECHNOLOGY CO., LTD.
2064 TAMARIN DR.
COLUMBUS, OH 43235 US
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Contact SHU-CHEN CHENG
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 09/09/2002
Decision Date 10/29/2003
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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