# K062256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Hill Laboratories Co.
- Decided: Feb 26, 2007 after 206 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001179 (2000). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031329: Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory), Dynatronics Corp. (2003) Summary page 3.
- DEN040009: Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK), Hamilton Thorne Biosciences (2004). 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.

## Most influential descendants
- K072256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model (2008), 1 descendant of its own
- K090250: Electro-Light Therapy (2010), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K062256
Methodology: https://510kreport.com/methodology