Therapy EC, Therapy XT

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232813

by Dmc Importacao E Exportacao De Equipamentos Ltda

Identifiers

510(k) Number: K232813 FDA 510(k)
FDA Product Code: NHN FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.5500 FDA 510(k)
Regulation Number: 890.5500 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Therapy EC and Therapy XT are powered light-based laser non-thermal instruments. They are designed to provide a non-heating effect for adjunctive use in pain therapy.

These devices are regulated under FDA 510(k) clearance K232813 as Class II medical devices. They fall under the physical medicine specialty and are categorized by product code NHN.

Frequently asked questions

What is the primary function of the Therapy EC and Therapy XT?

These devices are powered light-based laser instruments designed to provide a non-heating effect. They are intended for adjunctive use in pain therapy.

How are these devices classified for regulatory purposes?

The Therapy EC and Therapy XT are classified as Class II medical devices under the physical medicine specialty. They are regulated under FDA 510(k) clearance K232813 and fall under product code NHN.

Who is the manufacturer of these laser instruments?

The Therapy EC and Therapy XT are manufactured by DMC Importacao E Exportacao De Equipamentos Ltda, based in Sao Carlos, Brazil.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Therapy EC, Therapy XT (K232813) — FDA 510 (k) | Innolitics, Dmc Importacao E Exportacao DE Equipamentos Ltda FDA 510(k), K232813 - Therapy EC | FDA 510 (k), Therapy EC, Therapy XT 510 (k) K232813 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K232813	Class II	Active

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Manufacturer

Manufacturer: Dmc Importacao E Exportacao De Equipamentos Ltda

Sources (1)

FDA 510(k) K232813 24 fields · synced Sep 22, 2026