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510(k) K201958

ETD Family of Electrotherapy Devices by Therasigma, LLC — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2020
Date Received
July 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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