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510(k) K202725

ETD4000 by Therasigma, LLC — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
September 17, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Therasigma, LLC

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  • K070890 — EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (June 29, 2007)