Cleared Traditional

ETD4000

K202725 · Therasigma, LLC · Neurology

Mar 2021

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K202725 is an FDA 510(k) clearance for the ETD4000, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Therasigma, LLC (Washougal, US). The FDA issued a Cleared decision on March 26, 2021, 190 days after receiving the submission on September 17, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K202725 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2020
Decision Date	March 26, 2021
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement