# K041920: Infinity Plus Electrotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jan 21, 2005 after 189 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: 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.
- K982324: Vectra Pro Models 2 and 4, Chattanooga Group, Inc. (1999) Summary page 1.

## Indications for use
The Infinity Plus is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation/Russian (NMES), conventional interferential, and premodulated interferential current stimulation (IFS). As a NMES device, the Infinity Plus device is indicated for the following conditions: * Retarding or preventing disuse atrophy * Maintaining or increasing range of motion * Re-educating muscles * Relaxation of muscle spasm * Increasing local blood circulation * Prevention of venous thrombosis of the calf muscles immediately after surgery As an IFS device, the Infinity Plus is indicated for the following conditions: * Symptomatic relief of acute pain * Symptomatic relief and management of chronic intractable pain * As an adjunctive treatment for post surgical and post traumatic acute pain

Source page: https://510kreport.com/device/K041920
Methodology: https://510kreport.com/methodology