# K042057: Infinity Electrotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Dec 17, 2004 after 140 days
- Product code: LIH (Interferential Current Therapy)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931781 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021100: 300 PV Complete Electrotherapy System, Empi (2002) Summary page 1.
- K030254: Interferential Stimulator, Model RTM1000, Ryan Telemedicine (2003) Summary page 1.

## Indications for use
The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions: * Symptomatic relief of acute pain * Symptomatic relief and management of chronic intractable pain * Symptomatic relief for post-surgical and post-traumatic acute pain

Source page: https://510kreport.com/device/K042057
Methodology: https://510kreport.com/methodology