FDA 510(k)

Therapy US

K-Number: K252273 · 2025-12-12

ApplicantDmc Importação E Exportação DE Equipamentos Ltda

Decision Date2025-12-12

Product CodeNHN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation K212189FibroLuxMulti Radiance Medical

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.