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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K201958
Device Name ETD Family of Electrotherapy Devices
Applicant
TheraSigma, LLC
6040 South Grant St. Suite 100
Washougal,  WA  98671
Applicant Contact Jim Klett
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received07/14/2020
Decision Date 08/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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