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FDA 510(k) Application Details - K191938
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K191938
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Heat In A Click LLC.
1975 Tigertail Blvd
Dania, FL 33004 US
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Contact
Guy Levi
Other 510(k) Applications for this Contact
Regulation Number
890.5850
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Classification Product Code
NGX
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More FDA Info for this Product Code
Date Received
07/19/2019
Decision Date
08/28/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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