510(k) · Cleared
ClearedVectra Combo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group, Inc. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Feb 1, 1999 after a 214-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 1, 1999
- Review
- 214 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK982317 Vectra ComboChattanooga Group, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK071677 SRT II Muscle StimulatorTherapeutic Innovations, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK040121 Dermawave 5000 Combi Max SystemDermawave, LLC · 2004
- Descendant · cites it directly · 0 of its ownK023050 Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL…Reliant Technologies, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K071677SRT II Muscle StimulatorTherapeutic Innovations, Inc. · 2008 · cites it directly0descendants
- K040121Dermawave 5000 Combi Max SystemDermawave, LLC · 2004 · cites it directly0descendants
- K023050Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound…Reliant Technologies, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982317 | Vectra Combo | Chattanooga Group, Inc. | 1999 | — |
| +1 | K071677 | SRT II Muscle Stimulator | Therapeutic Innovations, Inc. | 2008 | — |
| +1 | K040121 | Dermawave 5000 Combi Max System | Dermawave, LLC | 2004 | — |
| +1 | K023050 | Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono… | Reliant Technologies, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071677 (Therapeutic Innovations, Inc., 2008) has gone furthest, with 0 descendants of its own.
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.
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?
For Ultrasound Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C. For VMS, Russian, Monophasic Hi-Volt Relaxation of muscle spasms Prevention…
Read the full statement (114 words)
For Ultrasound
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C.
For VMS, Russian, Monophasic Hi-Volt
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated
Symptomatic relief of chronic, intractable pain
Management of pain associated with post-traumatic or post-operative conditions
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982317: Vectra Combo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982317
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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