ETD4000

FDA 510(k) K202725 · Therasigma, LLC

Substantially Equivalent

510(k) numberK202725

Submission

Device name
ETD4000
Applicant
Therasigma, LLC
Washougal, WA, US
Received
September 17, 2020
Decision date
March 26, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LIH – Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was ETD4000 cleared by the FDA?

ETD4000 (K202725) received a 510(k) decision of Substantially Equivalent on March 26, 2021, 190 days after the submission was received.

What is the product code of K202725?

The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.