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MyoCycle Home, MyoCycle Pro

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170132

by Myolyn, LLC

Identifiers

510(k) Number
K170132 FDA 510(k)
FDA Product Code
GZI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5810 FDA 510(k)
Regulation Number
882.5810 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MyoCycle Home and MyoCycle Pro are external functional neuromuscular stimulators designed to facilitate muscle re-education, prevent muscle atrophy, and improve neuromuscular function. Classified as neuromuscular stimulators, these devices deliver functional electrical stimulation (FES) to promote therapeutic exercise, reduce spasms, and enhance blood flow and range of motion in patients with neuromuscular conditions.

These systems are intended for home and clinical use, respectively, and are supplied as reusable medical devices. The MyoCycle Home and Pro are FDA-cleared under 510(k) K170132, with both models adhering to regulation 882.5810. They are not MRI-compatible and require proper storage in a clean, dry environment to maintain functionality. No single-use or sterility claims are specified in the regulatory data.

Frequently asked questions

What are the MyoCycle Home and Pro neuromuscular stimulators primarily used for?

The MyoCycle Home and Pro are designed to facilitate muscle re-education, prevent muscle atrophy, and improve neuromuscular function. They deliver functional electrical stimulation (FES) to promote therapeutic exercise, reduce spasms, and enhance blood flow and range of motion in patients with neuromuscular conditions. These devices are particularly useful for patients requiring targeted muscle activation and rehabilitation.

Are the MyoCycle Home and Pro single-use or reusable devices?

Both the MyoCycle Home and Pro are supplied as reusable medical devices. This means they are intended for repeated use in clinical or home settings, provided they are properly maintained and stored according to manufacturer guidelines. Reusability helps ensure cost-effectiveness and consistent performance over time.

What storage conditions are required for the MyoCycle Home and Pro?

The MyoCycle Home and Pro must be stored in a clean, dry environment to maintain their functionality. Proper storage is critical to prevent damage from moisture or contaminants, which could affect the device’s performance and safety. Always follow the manufacturer’s instructions for storage to ensure optimal use.

Can the MyoCycle Home and Pro be used in an MRI environment?

No, the MyoCycle Home and Pro are not MRI-compatible. Using these devices in an MRI environment poses a risk of interference or damage to the device, as well as potential harm to the patient. Always verify compatibility with MRI equipment before use in such settings.

What regulatory approvals do the MyoCycle Home and Pro hold?

The MyoCycle Home and Pro are FDA-cleared under 510(k) number K170132, with both models adhering to regulation 882.5810. This clearance indicates that the devices meet FDA standards for safety and effectiveness as external neuromuscular stimulators. Always refer to the manufacturer’s documentation for the most up-to-date regulatory information.

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: MyoCycle Home FES Therapy System | MYOLYN, MYOLYN Innovative Stimulation Solutions for Home and Clinic, Myocycle Home | FES Theraputic Exercise at Home, Myocycle Pro Fes Cycling Therapy System | Myolyn, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Myolyn, LLC

Sources (1)

  • FDA 510(k) K170132 24 fields · synced Oct 1, 2026