FDA 510(k) Application Details - K231575

Device Classification Name Interferential Current Therapy

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510(K) Number K231575
Device Name Interferential Current Therapy
Applicant Artaflex Inc.
181 Whitehall Drive
Markham L3T 9T1 CA
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Contact Gerry Iuliano
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Regulation Number 000.0000

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Classification Product Code LIH
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Date Received 05/31/2023
Decision Date 02/08/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K231575


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