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EMS - Magnetika

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241601

by Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

Identifiers

510(k) Number
K241601 FDA 510(k)
FDA Product Code
NGX FDA 510(k)
Models / Variants
FlexPulse FDA 510(k)
MagnaCore FDA 510(k)
Magnetika 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 EMS FlexPulse, MagnaCore, and Magnetika are powered muscle stimulators designed to facilitate neuromuscular electrical stimulation (NMES). These devices deliver controlled electrical impulses to stimulate muscle contractions, aiding in rehabilitation, muscle strengthening, and pain management for patients with neuromuscular or musculoskeletal conditions. They fall under the regulatory classification of powered muscle stimulators as defined by 21 CFR 890.5850.

These devices are intended for use in clinical and home settings, supplied as reusable medical equipment. They are regulated under the FDA’s 510(k) clearance process, with the FlexPulse, MagnaCore, and Magnetika models cleared under submission K241601. No specific sterility or MRI safety information is provided in the regulatory data, and their operational parameters are governed by the manufacturer’s instructions for use. The devices are classified as Class II under the FDA’s regulatory framework.

Frequently asked questions

Are these EMS devices meant for single-use or can they be reused in a clinical setting?

The EMS FlexPulse, MagnaCore, and Magnetika are explicitly described as reusable medical equipment, meaning they are designed for repeated use in both clinical and home settings. Since they are not labeled as single-use, proper cleaning and maintenance per the manufacturer’s instructions are required to ensure safe and effective operation across multiple patients or sessions.

What types of conditions or patients would these muscle stimulators be used for, based on their intended purpose?

These devices are intended for neuromuscular electrical stimulation (NMES) to aid in rehabilitation, muscle strengthening, and pain management for patients with neuromuscular or musculoskeletal conditions. While the exact clinical indications are not detailed, their design aligns with common uses like post-injury recovery, muscle atrophy prevention, or chronic pain relief—typically under professional supervision or for home use as directed by a healthcare provider.

How are these devices regulated by the FDA, and what does the ‘510(k) clearance’ mean for buyers or clinicians?

The FlexPulse, MagnaCore, and Magnetika models are cleared under the FDA’s 510(k) process, specifically submission K241601, which means they have been determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms the device meets FDA safety and effectiveness requirements for powered muscle stimulators (classified under 21 CFR 890.5850) and can legally be sold in the U.S. without further approval for its intended uses.

Are there any special storage requirements for these EMS devices, such as temperature or handling conditions?

The provided regulatory data does not specify sterility or storage conditions for these reusable devices. However, since they are classified as reusable medical equipment, standard practices for electrical medical devices—such as protecting them from moisture, extreme temperatures, and physical damage—should be followed. Always refer to the manufacturer’s instructions for use for device-specific storage guidelines to maintain functionality and safety.

What distinguishes the FlexPulse, MagnaCore, and Magnetika models from each other, and how might a buyer choose between them?

The regulatory data does not provide technical specifications or distinctions between the FlexPulse, MagnaCore, and Magnetika models beyond their shared classification as powered muscle stimulators. Buyers or clinicians would need to consult the manufacturer’s documentation or sales representatives for details on differences in features (e.g., electrode types, stimulation protocols, or user interfaces) to determine which model best fits their clinical or home-use needs. The choice may depend on factors like patient population, treatment goals, or ease of 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: EMS (FlexPulse, MagnaCore, Magnetika) (K241601) — FDA 510(k ..., PDF February 25, 2025 CPMT LASER (Canadian Pioneer Medical Technology ..., PDF K241601 - EMS (FlexPulse, MagnaCore, Magnetika)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

Sources (1)

  • FDA 510(k) K241601 24 fields · synced Oct 6, 2026