# K121059: Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim

- Pathway: 510(k) (Abbreviated)
- Applicant: Zimmer Medizinsystems GmbH
- Decided: Aug 7, 2012 after 123 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- 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 K954411 (1996). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 2.
- K954411: Galva-5-M, Zimmer Elektromedizin GmbH (1996) Summary page 2.
- K952536: SONO 5, Zimmer Elektromedizin GmbH (1996) Summary page 2.

## Most influential descendants
- K161628: JAS Pulse (TM) Ultrasonic Therapy (2016), 3 descendants of its own
- K241099: Plasonic (Plasonic) (2024), 2 descendants of its own
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (2026), 0 descendants of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own

## Indications for use
Ultrasound therapy: Relief of pain muscle spasms and joint contractures Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis Bursitis with slight calcification Myositis Soft tissue injuries Shortened tendons due to past injuries and scar tissues Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness. Capsular scarring Electrotherapy: For Medium Frequency, Monophasic Currents, Biphasic Symmetric Currents and High Voltage Relaxation of muscle spasm Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion For IFC, Premodulated, Microcurrent, Asymmetric Biphasic Currents and Symmetric Biphasic- Currents Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain Ultrasound therapy: Relief of pain, muscle spasms and joint contractures Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis Bursitis with slight calcification Myositis Soft tissue injuries Shortened tendons due to past injuries and scar tissues Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness Capsular scarring Electrotherapy: For Medium Frequency, Monophasic Currents, Biphasic Symmetric Currents and High Voltage Relaxation of muscle spasm Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion For IFC, Premodulated Microcurrent, Asymmetric Biphasic Currents and Symmetric Biphasic Currents Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain

Source page: https://510kreport.com/device/K121059
Methodology: https://510kreport.com/methodology