Cleared Traditional

K201958 - ETD Family of Electrotherapy Devices (FDA 510(k) Clearance)

K201958 · Therasigma, LLC · Physical Medicine device

Aug 2020

Decision

21d

Days

Class 2

Risk

K201958 is an FDA 510(k) clearance for the ETD Family of Electrotherapy Devices. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Therasigma, LLC (Washougal, US). The FDA issued a Cleared decision on August 4, 2020, 21 days after receiving the submission on July 14, 2020.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K201958 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 2020
Decision Date	August 04, 2020
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement