ETD Family of Electrotherapy Devices
K-Number: K201958 · 2020-08-04
ApplicantTherasigma, LLC
Decision Date2020-08-04
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ETD Family of Electrotherapy Devices is a medical device manufactured by Therasigma, LLC. It received FDA 510(k) clearance on 2020-08-04 under approval number K201958. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ETD Family of Electrotherapy Devices?
ETD Family of Electrotherapy Devices is a medical device that received FDA 510(k) clearance on 2020-08-04. It is manufactured by Therasigma, LLC. The 510(k) number is K201958.
When was ETD Family of Electrotherapy Devices approved by the FDA?
ETD Family of Electrotherapy Devices received FDA 510(k) clearance on 2020-08-04, under approval number K201958.
What company makes ETD Family of Electrotherapy Devices?
ETD Family of Electrotherapy Devices is manufactured by Therasigma, LLC.
What is the FDA product code for ETD Family of Electrotherapy Devices?
The FDA product code for ETD Family of Electrotherapy Devices is IPF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.