510(k) · Cleared
ClearedHF54 Combination Ultrasound Interferential and Premodulated Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Feb 26, 2007 as substantially equivalent to K031329 (Dynatronics Corp., 2003) and 1 other predicate after a 206-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Feb 26, 2007
- Review
- 206 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001179 (2000). 8 ancestors in all, the oldest K941461 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- This deviceK062256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2007
- Descendant · cites it directly · 1 of its ownK072256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2008
- Descendant · 2 generations on · 0 of its ownK090250 Electro-Light TherapyHill Laboratories Co. · 2010
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 |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| 0 (this device) | K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | Hill Laboratories Co. | 2007 | — |
| +1 | K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System… | Hill Laboratories Co. | 2008 | — |
| +2 | K090250 | Electro-Light Therapy | Hill Laboratories Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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 IMI? 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 IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Summary page 3…NameC i Manufacturer Class K031329 Solaris Model 708 and 709 Dynatronics 2 I tF54 and HF023 510(k)… | 2003 |
| * | DEN040009 | Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK) Our reading of the summary gave K031239, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040009, Hamilton Thorne Zona Infrared Laser Optical System (Zilos… (Hamilton Thorne Biosciences), granted Nov 4, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with… | 2008 | 1 |
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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K072256 (Hill Laboratories Co., 2008) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K031329.
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HF54 is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain Muscle Spasms joint contractures The combination ultrasound & electrotherapy modes offer deep heat…
Read the full statement (209 words)
The HF54 is indicated for:
Pain relief for:
Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain.
Ultrasound therapy is available from the HF54 and indicated for:
Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as:
Relief of pain
Muscle Spasms
joint contractures
The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using one or two ultrasound applicators. The second ultrasound applicator is optional.
An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for:
Temporary increases in local blood flow and circulation
Temporary relief of minor muscle and joint aches
Temporary relief of pain and stiffness
Relaxation of muscles
Temporary relief (or relaxation) of muscle spasms
Temporary relief of minor pain and stiffness associated with arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062256
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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