# K021100: 300 PV Complete Electrotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jun 18, 2002 after 75 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 K931781 (1993). 3 ancestors in all.
48 later devices descend from it; 10 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951951: Focus Model 795 Unit, Empi (1996) Summary page 1.
- K931781: Jace Tri-Stim Device, Jace Systems, Inc. (1993). Our reading of the summary gave K931871, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words.
- K000114: RS-4M+Muscle Stimulator, Rs Medical (2000)

## 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
- K170903: Compex Wireless USA (2017), 10 descendants of its own
- K110350: Kneehab XP (2011), 9 descendants of its own

## Indications for use
The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES). As a NMES device, the 300 PV 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 a TENS device, the 300 PV is indicated for the following conditions: Symptomatic relief and management of chronic, intractable pain Adjunctive treatment for post-surgical and post-trauma acute pain As an IFS device, the 300 PV is indicated for the following conditions: Symptomatic relief of acute pain Symptomatic relief and management of chronic pain As a FES device, the 300 PV is indicated for the following condition: Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient’s gait.

Source page: https://510kreport.com/device/K021100
Methodology: https://510kreport.com/methodology