FDA 510(k) Application Details - K143059

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K143059
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant TONE-A-MATIC INTERNATIONAL INC.
145 TRADERS BLVD EAST, UNIT 18
MISSISSAUGA L4Z-3L3 CA
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Contact MANUEL CHUCK
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 10/24/2014
Decision Date 01/26/2015
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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