510(k) · Cleared
ClearedSoleoline, Soleo Stim, Soleo Sono, Soleo Sonostim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Medizinsystems GmbH · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Aug 7, 2012 as substantially equivalent to K031077 (Chattanooga Group, 2003) and 2 other predicates after a 123-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Aug 7, 2012
- Review
- 123 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954411 (1996). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954411 Galva-5-MZimmer Elektromedizin GmbH · 1996
- This deviceK121059 Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimZimmer Medizinsystems GmbH · 2012
- Descendant · cites it directly · 3 of its ownK161628 JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016 · cites it directly3descendants
- K241099Plasonic (Plasonic)Hironic Co., Ltd. · 2024 · 2 generations on2descendants
- K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026 · 3 generations on0descendants
- K251334New Doublo 2.0Hironic Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954411 | Galva-5-M | Zimmer Elektromedizin GmbH | 1996 | — |
| 0 (this device) | K121059 | Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim | Zimmer Medizinsystems GmbH | 2012 | — |
| +1 | K161628 | JAS Pulse (TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016 | — |
| +2 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +3 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026 | — |
| +3 | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 2…cal) 4717 adams rd. P.O. Box 489 Hixson, Tennessee 37343-0489 510(k) number: . K031077 2. Device: Galva 5M Manufacturer: Zimmer MedizinSysteme GmbH (former Zimmer E… | 2003 |
| * | K954411 | Galva-5-MSummary page 2…Junikersstrasse 9 89231 Neu-Ulm Germany 510(1k) number: K954411 3. device: Sono 5 Manufacturer: Zimmer MedizinSysteme GmbH… | 1996 |
| * | K952536 | SONO 5Summary page 2…Junkersstrasse 9 89231 Neu-Ulm Germany 510(k) number: K952536 c.) Device Description The Soleoline has aclear contemporary color screen showing all parameters necessary for therapy as wella… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161628 | JAS Pulse (TM) Ultrasonic Therapy | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (250 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121059: Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121059
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026