FDA 510(k) Application Details - K202725

Device Classification Name Interferential Current Therapy

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510(K) Number K202725
Device Name Interferential Current Therapy
Applicant TheraSigma, LLC
4060 South Grant St.
Suite 102
Washougal, WA 98671 US
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Contact Jim Klett
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 09/17/2020
Decision Date 03/26/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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