Search Results
Found 9 results
510(k) Data Aggregation
K Number
K160614Device Name
Xcite Clinical Station
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2016-12-16
(288 days)
Product Code
IPF, GZI
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Xcite Clinical Station is intended for general rehabilitation for:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion
The Xcite system is for prescription use only.
Device Description
Xcite is a multichannel Functional Electrical Stimulation (FES) system that delivers electrical stimulation to peripheral nerves in a coordinated fashion to facilitate various activities. The system is composed of:
1. A tablet computer –
2. Up to two 6 channel stimulators
3. One or two stimulation cable(s) which connects the stimulator to cutaneous electrodes
4. cutaneous electrodes
5. an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
6. a mobile cart
Ask a Question
K Number
K103370Device Name
RT200
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2011-04-05
(139 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT200 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
The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT200 is for prescription use only.
Device Description
The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:
- a motorized elliptical ergometer (RTI part number SA110444)
- an FES controller with built in 6 channel stimulator (RTI part number SA109413)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- a stimwear 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 recumbent elliptical ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K103366Device Name
RT600
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2011-04-04
(139 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT600 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
The RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
Device Description
The RT600 is a Functional Electrical Stimulation (FES) upright elliptical ergometer which is composed of:
- a motorized upright ergometer (RTI part number SA211257)
- an FES controller with built in 6 channel stimulator (RTI part number SA109413)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- a stimwear garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)
This system allows a person with impaired lower extremity movement to undertake upright elliptical ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K090750Device Name
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2009-08-05
(138 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300 (adult and pediatric version) are intended for general rehabilitation for:
a. Relaxation of muscle spasms
b. Prevention or retardation of disuse atrophy
c. Increasing local blood circulation
d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
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.
Device Description
The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an optional motorized arm crank (RTI part number PP102663)
- an FES controller with built in 6 channel stimulator (RTI part number SA100090)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 stimulation channels)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- a stimwear 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 ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K072398Device Name
RT300-S AND RT300-SP FES CYCLE ERGOMETER
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2007-11-21
(86 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300 adult and pediatric versions are 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
The RT300 pediatric version is intended for population ages 4 to 12 years.
Device Description
The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an optional motorized arm crank (RTI part number PP102663)
- an FES controller / stimulator (RTI part number SA100090)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
This system allows a person with impaired upper or lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K071486Device Name
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2007-09-10
(103 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300-S (adult version) and RT300-SP (pediatric version) are 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
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
Device Description
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
1. a motorized cycle ergometer (RTI part number SA100047 for adults and 1 SA100044 for children)
2. an FES controller / stimulator (RTI part number SA100090)
3. a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
4. cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels and 10 muscle groups, RTI part number FA100015)
5. an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
6. an optional motorized arm crank (RTI part number PP102663)
7. an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data.
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K071113Device Name
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2007-07-05
(76 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300-S (adult version) and RT300-SP (pediatric version) are 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
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
Device Description
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- an optional motorized arm crank (RTI part number PP102663)
- an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data.
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K060032Device Name
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2006-03-10
(64 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
Device Description
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of
- a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
K Number
K050036Device Name
FES CYCLE ERGOMETER, MODEL RT300-S
Manufacturer
RESTORATIVE THERAPIES INC.
Date Cleared
2005-06-27
(171 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
RESTORATIVE THERAPIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:
- a. Relaxation of muscle spasms
- b. Prevention or retardation of disuse atrophy
- c. Increasing local blood circulation
- d. Maintaining or increasing range of motion
The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
Device Description
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Ask a Question
Page 1 of 1