# K050046: Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S

- Pathway: 510(k) (Traditional)
- Applicant: Compex Technologies, Inc.
- Decided: Apr 13, 2005 after 93 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: 1 generation back to K872976 (1987). 5 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926510: Staodyn Ems+2, Staodyne, Inc. (1993) Summary page 2.
- K923914: IF-II (TM), Model 7200, Medical Devices, Inc. (1992) Summary page 2.
- K921668: Staodyn Tuwave, Staodyne, Inc. (1992) Summary page 2.
- K872976: Tens Pals Plus, Axelgaard Mfg. Co., Ltd. (1987) Summary page 2.
- K970426: Valuetrode, Axelgaard Mfg. Co., Ltd. (1997) Summary page 2.

## Most influential descendants
- K093324: Empi Continuum (2010), 26 descendants of its own
- K124016: Empi Phoenix (2013), 25 descendants of its own
- K153704: Strive (2016), 24 descendants of its own
- K123354: Revitive IX (2013), 19 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own

## Indications for use
Interferential stimulation can be used for the following applications: * Relieve acute pain * Relieve and manage chronic pain * Relax muscle spasmns * Maintain and increase the range of motion * Increase local blood circulation Neuromuscular stimulation can be used for the following applications: * Relax muscle spasms * Prevent or retard disuse atrophy * Increase local blood circulation * Re-educate muscles * Maintain or increase the range of motion * Prevent venous thrombosis using immediate postsurgical stimulation on calf muscles Pulsed direct current stimulation can be used for the following applications: * 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 or increase of range of motion

Source page: https://510kreport.com/device/K050046
Methodology: https://510kreport.com/methodology