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510(k) Data Aggregation
K Number
K213925Device Name
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
Manufacturer
Myolyn, LLC
Date Cleared
2022-04-25
(130 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
Myolyn, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K170132Device Name
MyoCycle Home, MyoCycle Pro
Manufacturer
MYOLYN, LLC
Date Cleared
2017-04-25
(98 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
MYOLYN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MyoCycle is intended for general rehabilitation for:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
Device Description
The MyoCycle is a stationary FES cycle ergometer which is composed of:
1. a motorized cycle ergometer
2. an FES controller / stimulator
3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels)
4. cutaneous electrodes
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes:
1. Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
2. Home mode only stores data for one user
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