Search Results
Found 1 results
510(k) Data Aggregation
K Number
K162470Device Name
RT300 FES cycle ergometer
Manufacturer
Date Cleared
2017-07-11
(308 days)
Product Code
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
Restorative Therapies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RT300 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
5. Muscle re-education
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT300 is for prescription use only.
Device Description
The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
1. A motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
2. An optional motorized arm crank (RTI part number PP102663)
3. An FES controller with up to two 6 channel stimulators (RTI part number SA216172)
4. Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
5. A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
6. Cutaneous electrodes (up to 24 electrodes for up to 12 stimulation channels)
7. An interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
8. An interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
9. A garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)
This system allows a person with impaired upper or lower extremity movement to undertake cycle erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.
Ask a Question
Ask a specific question about this device
Page 1 of 1