← Back to catalogue

Sonicator Plus 920

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111482

by Mettler Electronics Corp.

Identifiers

510(k) Number
K111482 FDA 510(k)
FDA Product Code
IMG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5860 FDA 510(k)
Regulation Number
890.5860 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sonicator Plus 920 is a Stimulator, Ultrasound and Muscle device classified under Class II regulatory status, designed for applying therapeutic deep heat via ultrasound and electrical muscle stimulation. It combines two-channel functionality to deliver targeted physical therapy interventions for musculoskeletal and soft tissue conditions.

This device is supplied as a reusable, non-sterile medical instrument intended for use in physical medicine settings. It features 1/3 MHz ultrasound and electrical stimulation waveforms, with 90 user-defined protocols and 11 language options. Authorized under FDA 510(k) clearance (K111482), it adheres to 21 CFR 890.5860 standards for therapeutic ultrasound and muscle stimulators, ensuring compliance with regulatory requirements for therapeutic equipment.

Frequently asked questions

What types of conditions is the Sonicator Plus 920 designed to treat, and how does it achieve this?

The Sonicator Plus 920 is designed for musculoskeletal and soft tissue conditions by delivering therapeutic deep heat via ultrasound and electrical muscle stimulation. It uses 1/3 MHz ultrasound and electrical stimulation waveforms to target pain relief, tissue repair, and muscle activation. The device’s two-channel functionality and 90 user-defined protocols allow for customized treatment plans tailored to specific clinical needs.

Is the Sonicator Plus 920 intended for single-use or reusable applications, and what does this mean for maintenance?

The Sonicator Plus 920 is reusable and non-sterile, meaning it is meant for repeated use in clinical settings like physical medicine. Since it is not sterile, proper cleaning and maintenance per manufacturer guidelines are required between patient sessions to ensure hygiene and device longevity. Reusability also implies it should be serviced periodically to maintain performance.

How many treatment protocols are available, and why might this flexibility be important for clinicians?

The Sonicator Plus 920 offers 90 user-defined protocols, allowing clinicians to customize treatment parameters for different patient needs. This flexibility is important because musculoskeletal and soft tissue conditions vary widely—whether managing chronic pain, post-injury recovery, or muscle atrophy—so adaptable protocols help optimize therapeutic outcomes for diverse cases.

What languages does the device support, and how might this benefit clinical workflows?

The Sonicator Plus 920 supports 11 language options, which can streamline clinical workflows by accommodating multilingual staff or diverse patient populations. This feature reduces the need for additional translation tools and ensures that operators can comfortably navigate the device’s interface, minimizing errors and improving efficiency.

What regulatory pathway was followed for FDA clearance, and what does this mean for its clinical use?

The Sonicator Plus 920 was cleared via an FDA 510(k) pathway (K111482) under a Special Review with a Substantially Equivalent (SESE) determination. This means the device was compared to a legally marketed predicate and deemed equivalent in safety and effectiveness for its intended use—applying therapeutic deep heat via ultrasound and muscle stimulation—ensuring compliance with 21 CFR 890.5860 standards. Clinicians can rely on this clearance as evidence of regulatory validation for its clinical 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: PDF Combination with Ease- The Sonicator® Plus 920, Sonicator Plus 920 « The World Leader in Therapeutic Equipment, Sonicator Plus 920 Instruction Manual | Manualzz, Sonicator Plus 920 Mettler Electronics Corp. | Witmer Motor Service

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA 510(k) K111482 24 fields · synced Sep 19, 2026