FDA 510(k)

Therapy US

Numéro K : K252273 · 2025-12-12

DemandeurDmc Importação E Exportação DE Equipamentos Ltda

Date de décision2025-12-12

Code produitNHN

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Therapy US is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252273. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Therapy US?

Therapy US is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. The 510(k) number is K252273.

When did Therapy US receive FDA 510(k) clearance?

Therapy US received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252273.

Who is the listed applicant for Therapy US?

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

What is the FDA product code for Therapy US?

The FDA product code for Therapy US is NHN.

Essais cliniques associés

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Dispositifs connexes (Code : NHN)

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Source officielle

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