# K093324: Empi Continuum

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Mar 5, 2010 after 133 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: 3 generations back to K881114 (1988). 15 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 42 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 2.
- K061650: Select Tens, Model 4600S, Empi (2007) Summary page 2.
- K050046: Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S, Compex Technologies, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own

## Indications for use
As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation * Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: * Symptomatic relief and managernent 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 are for the following 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 As an FES device, the indications for tlie.following condition: *Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.

Source page: https://510kreport.com/device/K093324
Methodology: https://510kreport.com/methodology