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Provant Therapy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131979

by Regenesis Biomedical, Inc.

Identifiers

510(k) Number
K131979 FDA 510(k)
FDA Product Code
ILX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5290 FDA 510(k)
Regulation Number
890.5290 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Provant Therapy System is a shortwave diathermy device for use other than applying therapeutic deep heat. It is classified as a Class II by the FDA and is substantially equivalent to a predicate device. The device is indicated for use in physical medicine applications.

The system consists of a control unit housed in a UL-compliant injection-molded case made of high-impact ABS plastic and a treatment applicator attached to the control unit. It is supplied as a reusable system for use in clinical or home settings when prescribed by a health professional. The device operates under FDA 510(k) clearance K131979 with product code ILX.

Frequently asked questions

What is the Provant Therapy System used for?

The Provant Therapy System is indicated for use in physical medicine applications as a shortwave diathermy device for use other than applying therapeutic deep heat, meaning it delivers energy for therapeutic purposes without relying on deep tissue heating as its primary mechanism.

Is the Provant Therapy System reusable or single-use?

The Provant Therapy System is supplied as a reusable system, consisting of a control unit and treatment applicator designed for repeated use in clinical or home settings when prescribed by a health professional, not as a disposable or single-use device.

What components are included with the Provant Therapy System?

The system includes a control unit housed in a UL-compliant injection-molded case made of high-impact ABS plastic and a treatment applicator attached to the control unit, forming a complete reusable unit for therapy delivery.

Can the Provant Therapy System be used in home settings?

Yes, the Provant Therapy System is designed for use in both clinical and home settings, provided it is prescribed by a health professional, allowing patients to continue therapy outside of a clinic under appropriate guidance.

What regulatory pathway was used for the Provant Therapy System?

The Provant Therapy System received FDA 510(k) clearance under submission K131979, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device with product code ILX.

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: Regenesis Biomedical Introduces the New Provant Infinity, Regenesis Biomedical, Inc. 4201 Provant Therapy System, Provant Therapy System — FDA Class II Medical Device - MedEquip Directory, PDF Infinity - Regenesis

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Regenesis Biomedical, Inc.

Sources (1)

  • FDA 510(k) K131979 24 fields · synced Sep 26, 2026