FDA 510(k) Application Details - K994065

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K994065
Device Name Stimulator, Muscle, Powered
Applicant HOME WELLNESS WEST
9393 ACTIVITY RD.
SUITE F
SAN DIEGO, CA 92126 US
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Contact RICHARD M HARRIS
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/01/1999
Decision Date 04/04/2000
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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