# K072256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model

- Pathway: 510(k) (Traditional)
- Applicant: Hill Laboratories Co.
- Decided: Mar 12, 2008 after 212 days
- Product code: PFW (Stationary Ultrasonic Diathermy Device 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: 4 generations back to K001179 (2000). 9 ancestors in all.
1 later device descends 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)
- K062256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System, Hill Laboratories Co. (2007) Summary page 3.

## Most influential descendants
- K090250: Electro-Light Therapy (2010), 0 descendants of its own

## Indications for use
The HF54 interferential therapy and premodulated therapy 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 joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator’s manual, the applicator can be used in a hands- free manner (where the applicator remains stationary). 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/K072256
Methodology: https://510kreport.com/methodology