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Sonicator 720 (Model ME720)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K883228

by Mettler Electronics Corp.

Identifiers

510(k) Number
K883228 FDA 510(k)
FDA Product Code
IMI 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)

The Sonicator 720 (Model ME720) is an Ultrasonic Diathermy device designed for applying therapeutic deep heat. It delivers controlled ultrasound energy to promote tissue healing, reduce pain, and improve circulation in physical medicine applications.

This device is supplied as a reusable medical instrument and is classified under FDA regulation 890.5300. It operates within the physical medicine specialty and has received FDA 510(k) clearance (K883228) under the Traditional review pathway, classified as a Class II device. No specific sterility or MRI safety information is provided in the data.

Frequently asked questions

What is the primary clinical purpose of the Sonicator 720 (Model ME720) in physical medicine applications?

The Sonicator 720 is designed to deliver controlled ultrasound energy for therapeutic deep heat, which helps promote tissue healing, reduce pain, and improve circulation in physical medicine settings. This makes it useful for rehabilitation, musculoskeletal therapy, and other treatments requiring deep tissue stimulation.

Is the Sonicator 720 a single-use or reusable device, and what does this mean for maintenance?

The Sonicator 720 is explicitly described as a reusable medical instrument. This means it is intended for repeated use across multiple patients, requiring proper cleaning, disinfection, and maintenance between applications to ensure safety and functionality. Reusability also implies it may need periodic servicing to comply with manufacturer guidelines and regulatory standards.

How is the regulatory pathway for this device classified, and what does that imply for its use?

The Sonicator 720 received FDA 510(k) clearance (K883228) under the Traditional review pathway as a Class II device, classified under FDA regulation 890.5300 for Ultrasonic Diathermy. This classification means it is subject to stricter controls than Class I devices but does not require the same rigorous premarket approval as Class III. Clinicians should confirm compliance with current FDA guidelines and institutional protocols when integrating it into practice.

Are there any specific storage requirements mentioned for the Sonicator 720?

The provided data does not include explicit storage instructions for the Sonicator 720. However, as a reusable medical device, it should be stored in a clean, dry environment protected from physical damage or contamination. Manufacturers typically recommend following their operational manual for optimal storage practices, including any environmental conditions (e.g., temperature, humidity) that may affect performance or longevity.

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: K883228 - SONICATOR 720 (MODEL ME720) | FDA 510 (k), Sonicator 720 (model Me720) 510 (k) FDA Premarket Notification K883228 ..., METTLER 416451 Sonicator Me Therapeutic Ultrasound 720, SONICATOR 720 (MODEL ME720) (K883228) — FDA 510(k) | Innolitics, Mettler ME 7235 - 720 Applicator, 5 cm, 3.3 Mhz - Minnesota Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA 510(k) K883228 24 fields · synced Sep 19, 2026