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FDA 510(k) Application Details - K201958
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K201958
Device Name
Stimulator, Muscle, Powered
Applicant
TheraSigma, LLC
6040 South Grant St. Suite 100
Washougal, WA 98671 US
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Contact
Jim Klett
Other 510(k) Applications for this Contact
Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
07/14/2020
Decision Date
08/04/2020
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
Y
Expedited Review
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