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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Therasigma, LLC. It received FDA 510(k) clearance on 2020-08-04 under 510(k) 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. The listed applicant is Therasigma, LLC. The 510(k) number is K201958.

When did ETD Family of Electrotherapy Devices receive FDA 510(k) clearance?

ETD Family of Electrotherapy Devices received FDA 510(k) clearance on 2020-08-04, under 510(k) number K201958.

Who is the listed applicant for ETD Family of Electrotherapy Devices?

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 ETD Family of Electrotherapy Devices?

The FDA product code for ETD Family of Electrotherapy Devices is IPF.

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.

K202725ETD4000

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

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