510(k) · Cleared
ClearedUltra V Therapeutic Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel Tech., Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Jul 7, 2000 as substantially equivalent to K923076 (Excel Tech., Ltd., 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Jul 7, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923076 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923076 Ultra SXExcel Tech., Ltd. · 1993
- This deviceK001166 Ultra V Therapeutic UltrasoundExcel Tech., Ltd. · 2000
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923076 | Ultra SX | Excel Tech., Ltd. | 1993 | — |
| 0 (this device) | K001166 | Ultra V Therapeutic Ultrasound | Excel Tech., Ltd. | 2000 | — |
| +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 |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K944065 | Excel Tech Ultra Max (formerly called Ultra SX) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…300 (905) 829-5304 [email protected] Therapcutic Ultrasound Stimulator, Ultrasound and Muscle, for use in spplying Therapeutic Deep Heat Excel Tech Ultra Max [510(k) K944065, formerly called Ultra SX]. The XLTek Ultra V is a Therapeutic Ultrasound The Ultra V is similar in design and function to the… | |
| * | K923076 | Ultra SXSummary page 1…0(k) K944065, formerly called Ultra SX]. The XLTek Ultra V is a Therapeutic Ultrasound The Ultra V is similar in design and function to the Excel Tech Ultra SX [S10(k) K923076, also known as the Ultra Max]. The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep… | 1993 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K040121 (Dermawave, LLC, 2004) 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?
The Ultra V provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of:
1. Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
2. Soft tissue injurics and shortened tendons due to past injurics and scar tissue
3. Joint contractures resulting from capsular tightness and scarring.
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/K001166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001166: Ultra V Therapeutic Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001166
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026