FDA 510(k)

Therapy EC, Therapy XT

K-Nummer: K232813 · 2024-12-19

AntragstellerDmc Importacao E Exportacao DE Equipamentos Ltda

Entscheidungsdatum2024-12-19

ProduktcodeNHN

BeratungsausschussPM

EntscheidungSubstantially Equivalent

Produktübersicht

Therapy EC, Therapy XT is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K232813. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Therapy EC, Therapy XT?

Therapy EC, Therapy XT is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Dmc Importacao E Exportacao DE Equipamentos Ltda. The 510(k) number is K232813.

When did Therapy EC, Therapy XT receive FDA 510(k) clearance?

Therapy EC, Therapy XT received FDA 510(k) clearance on 2024-12-19, under 510(k) number K232813.

Who is the listed applicant for Therapy EC, Therapy XT?

The FDA 510(k) record lists Dmc Importacao E Exportacao DE Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therapy EC, Therapy XT?

The FDA product code for Therapy EC, Therapy XT is NHN.

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Verwandte Geräte (Code: NHN)

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K231409Erchonia FX-405Erchonia Corporation K212189FibroLuxMulti Radiance Medical

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