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ETD Family of Electrotherapy Devices

by Therasigma, LLC

510(k) K201958

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201958 Date4 Aug 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ETD Family of Electrotherapy Devices is a Class 2 Physical Medicine device with product code IPF. It is a powered muscle stimulator cleared through the FDA 510(k) pathway as substantially equivalent to a predicate device.

The device was cleared via the Traditional 510(k) pathway after a 21-day review, with decision date August 4, 2020, and K number K201958. It is manufactured by Therasigma, LLC in Washougal, Washington, and is authorized for distribution in the United States.

Other devices from Therasigma, LLC

  • ETD4000

    Class II

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ETD Family of Electrotherapy Devices used for?

    The ETD Family of Electrotherapy Devices is a powered muscle stimulator classified as a Class 2 Physical Medicine device with product code IPF. It is designed for therapeutic muscle stimulation applications.

  • How is the ETD Family of Electrotherapy Devices supplied?

    The device is manufactured by Therasigma, LLC in Washougal, Washington, and is authorized for distribution in the United States. Specific supply details regarding packaging or quantities are not provided in the available information.

  • What is the regulatory status of the ETD Family of Electrotherapy Devices?

    The device was cleared through the FDA 510(k) pathway as substantially equivalent to a predicate device. It received clearance via the Traditional 510(k) pathway after a 21-day review, with a decision date of August 4, 2020, and K number K201958.

  • Is the ETD Family of Electrotherapy Devices reusable or single-use?

    The available information does not specify whether the ETD Family of Electrotherapy Devices is designed for single-use or multiple uses. This detail would typically be found in the device's instructions for use or product labeling.