FDA 510(k)

ETD4000

K-Number: K202725 · 2021-03-26

Decision Date2021-03-26

Product CodeLIH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ETD4000 is the device name listed in this FDA 510(k) record. The listed applicant is Therasigma, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K202725. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETD4000?

ETD4000 is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Therasigma, LLC. The 510(k) number is K202725.

When did ETD4000 receive FDA 510(k) clearance?

ETD4000 received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202725.

Who is the listed applicant for ETD4000?

The FDA 510(k) record lists Therasigma, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETD4000?

The FDA product code for ETD4000 is LIH.

Other records listing Therasigma, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201958ETD Family of Electrotherapy Devices

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.