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Empi Phoenix

FDA 510(k)

Class II (US FDA 510(k))

510(k) K124016

by Djo, Llc

Identifiers

510(k) Number
K124016 FDA 510(k)
FDA Product Code
IPF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Empi Phoenix is a multifunctional electrotherapy device designed to provide neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation, and pulsed current stimulation. It is intended to assist in the treatment of muscle atrophy as a supplement to physical therapy before and after surgery.

This device is supplied as a conductive garment and is subject to FDA 510(k) clearance under K124016. Users should consult the provided user manual for operational guidance and safety information. The device is manufactured by DJO, LLC.

Frequently asked questions

What is the primary clinical use of the Empi Phoenix?

The Empi Phoenix is designed to provide neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation, and pulsed current stimulation. It is intended to assist in the treatment of muscle atrophy as a supplement to physical therapy both before and after surgical procedures.

How is the Empi Phoenix device supplied?

The device is supplied as a conductive garment. Users should refer to the provided user manual for specific operational guidance and safety information regarding the application and use of the garment.

What is the regulatory status of this device?

The Empi Phoenix is subject to FDA 510(k) clearance under submission number K124016. This indicates that the device has been found to be substantially equivalent to other legally marketed devices.

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: Empi Phoenix 510 (k) FDA Premarket Notification K124016 DJO, LLC, EMPI PHOENIX (K124016) — FDA 510 (k) | Innolitics, EMPI PHOENIX USER MANUAL Pdf Download | ManualsLib, 510 (k) K124016 — EMPI PHOENIX — RegDataLab, Empi Phoenix - DJO Global | Lower Extremity Review Magazine

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA 510(k) K124016 24 fields · synced Sep 26, 2026