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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K202725
Device Name ETD4000
Applicant
Therasigma, LLC
4060 S. Grant St.
Suite 102
Washougal,  WA  98671
Applicant Contact Jim Klett
Correspondent
Therasigma, LLC
4060 S. Grant St.
Suite 102
Washougal,  WA  98671
Correspondent Contact Jim Klett
Regulation Number882.5890
Classification Product Code
LIH  
Date Received09/17/2020
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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