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Storz Medical Magnetolith Muscle Stimulator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203710

by Storz Medical AG

Identifiers

510(k) Number
K203710 FDA 510(k)
FDA Product Code
IPF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Storz Medical Magnetolith Muscle Stimulator is an extracorporeal magnetotransduction therapy (EMTT) device designed for non-invasive treatment of musculoskeletal disorders. It delivers high-energy electromagnetic pulses to induce weak electric currents in targeted tissues, aiding in muscle relaxation and rehabilitation without direct contact.

This device is supplied as a reusable medical instrument and is regulated under the FDA 510(k) and MDD frameworks. It is intended for clinical use in physical medicine settings, with no specific sterility requirements stated beyond standard pre-procedure hygiene. The device operates under electromagnetic principles and is classified under product code IPF for physical medicine applications.

Frequently asked questions

What types of musculoskeletal conditions can the Magnetolith Muscle Stimulator help treat, and how does it work?

The Magnetolith Muscle Stimulator is designed for non-invasive treatment of musculoskeletal disorders by delivering high-energy electromagnetic pulses. These pulses induce weak electric currents in targeted tissues, promoting muscle relaxation and aiding rehabilitation. It is particularly suited for clinical use in physical medicine settings to support recovery without direct contact, such as for muscle spasms, stiffness, or post-injury rehabilitation.

Is the Magnetolith Muscle Stimulator single-use or reusable, and what hygiene practices should be followed?

The Magnetolith Muscle Stimulator is a reusable medical instrument, meaning it is intended for repeated use across multiple patients. Since it is not sterile, standard pre-procedure hygiene practices—such as cleaning and disinfection—must be followed between uses to maintain safety and prevent contamination. Specific sterilization is not required or recommended.

How is the regulatory status of this device determined, and what does that mean for clinical use?

The Magnetolith Muscle Stimulator is authorized under the FDA 510(k) pathway and the Medical Device Directive (MDD). The FDA classification as substantially equivalent (SESE) under product code IPF (Physical Medicine) means it has been determined to have the same intended use and technological characteristics as a legally marketed device. Clinically, this indicates it meets regulatory standards for safety and effectiveness in physical medicine applications, such as muscle stimulation and rehabilitation.

What should clinicians consider when storing the Magnetolith Muscle Stimulator to ensure optimal performance?

Since the Magnetolith Muscle Stimulator is reusable and not sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage helps maintain the device’s electromagnetic functionality and longevity. Follow manufacturer guidelines for maintenance to ensure consistent performance during clinical use.

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: MAGNETOLITH ultra+ - STORZ MEDICAL, MAGNETOLITH ultra+ - STORZ MEDICAL, Storz Magnetolith EMTT - Vale Medical, Storz Medical MAGNETOLITH Muscle Stimulator by Storz Medical AG | FDA ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Storz Medical AG

Sources (2)

  • FDA 510(k) K203710 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026