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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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MANUEL CHUCK
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
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More FDA Info for this Product Code
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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