HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072256 FDA 510(k)
- FDA Product Code
- PFW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5300 FDA 510(k)
- Regulation Number
- 890.5300 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a stationary ultrasonic diathermy device for use in applying therapeutic deep heat, combining ultrasound with interferential and premodulated stimulation currents. It is designed for physical medicine applications and includes optional hands-free operation via an infrared therapy probe (HF023) as an accessory.
The system is supplied as a reusable, non-sterile device intended for use in clinical settings. It operates with two channels of interferential and premodulated muscle stimulation current, which can be used independently or in combination with ultrasound through one or two soundheads. The device received FDA 510(k) clearance (K072256) as substantially equivalent to a predicate device and is classified as a Class II medical device under regulation number 890.5300.
Frequently asked questions
What is the HF54 device used for?
The HF54 is a stationary ultrasonic diathermy device designed to apply therapeutic deep heat by combining ultrasound with interferential and premodulated stimulation currents, intended for physical medicine applications in clinical settings.
Is the HF54 device sterile or single-use?
The HF54 is supplied as a reusable, non-sterile device, meaning it is intended for repeated use in clinical environments after appropriate cleaning and is not provided in a sterile condition nor designed for single-use disposal.
What accessories are available for hands-free operation of the HF54?
The HF54 supports optional hands-free operation through the infrared therapy probe model HF023, which is sold as an accessory to enable automated or clinician-independent ultrasound delivery during treatment.
How many channels of stimulation does the HF54 provide?
The HF54 operates with two independent channels of interferential and premodulated muscle stimulation current, which can be used separately or combined with ultrasound output from one or two soundheads for customized therapy.
What regulatory pathway was used for the HF54 device?
The HF54 received FDA 510(k) clearance under submission K072256, determined to be substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation 890.5300 for physical medicine applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HF54+ Hands-Free Therapeutic Ultrasound Combo Machine, HF54+ Therapeutic Ultrasound Combo Machine Hands-Free, Hf54 Combination Ultrasound Interferential and Premodulated Stimulation ..., Hf54 Combination Ultrasound Interferential and Premodulated Stimulation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072256 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill Laboratories Co.
Sources (1)
- FDA 510(k) K072256 24 fields · synced Sep 25, 2026