# K124016: Empi Phoenix

- Pathway: 510(k) (Abbreviated)
- Applicant: Djo, LLC
- Decided: May 6, 2013 after 130 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881114 (1988). 19 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090632: Compex Rehab, Chattanooga Group (2009) Summary page 1.
- K093324: Empi Continuum, Empi (2010) Summary page 1.

## Most influential descendants
- K153704: Strive (2016), 24 descendants of its own
- K170903: Compex Wireless USA (2017), 10 descendants of its own
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K170918: Compex Sport Elite (2017), 4 descendants of its own

## Indications for use
The Empi Phoenix is a multifunctional electrotherapy device with various treatment modes that allow for neuromuIscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) and pulsed current stimulation (PCs). As an NMWES device, indicationsarefor the followving conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation As a TENS device, indications arefor the followving conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis As a pulsed current device, indications arefor the fod/owing conditions: - Reduction of edema (under negative electrode) - Reduction of muscle spasm - Influencing local blood circulation (under negative electrode) - Retardation or prevention of disuse atrophy - Facilitation of voluntary motor function - Maintenance of increase of range of motion

Source page: https://510kreport.com/device/K124016
Methodology: https://510kreport.com/methodology