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510(k) Data Aggregation

    K Number
    K162683
    Device Name
    RehaStim 2
    Manufacturer
    HASOMED GmbH
    Date Cleared
    2017-02-03

    (130 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HASOMED GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RehaStim 2 stimulator 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 RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.
    Device Description
    RehaStim 2 is a 8 channel External Functional Neuromuscular Stimulator. RehaStim 2 can be used as a stand-alone device or in combination with an external motion trainer for cycling or walking applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. A connection cable enables the RehaStim 2 to receive motion data from the external movement exerciser device for walking or cycling applications in order to apply electrical stimulation synchronized with the movement. The stimulation is performed according to the motion data. The stimulation parameters can be configured inside the stimulator. Electrode lead wires are used to connect RehaStim2 output and electrodes on skin.
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    K Number
    K132416
    Device Name
    REHASTIM 2, ERIGOPRO (FES)
    Manufacturer
    HASOMED GMBH
    Date Cleared
    2014-05-28

    (299 days)

    Product Code
    GZI, BXB, INQ
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HASOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ErigoPro is intended for medical purposes such as to increase to an upright or standing position in patients with circulatory, neurological, or musculoskeletal conditions. ErigoPro is also used for: - 1. Relaxation of muscle spasms - 2. Prevention or retardation of disuse atrophy / redevelop muscles - 3. Increasing local blood circulation - 4. Maintaining or increasing joint range of motion The ErigoPro is for prescription use only.
    Device Description
    The Erigo is an early rehabilitation robotic device consisting of a verticalization table and an integrated leg movement mechanism. By moving the patient's legs, cyclic leg loading is applied to the lower limbs of the patient during early verticalization. The Erigo is controlled via a PC. The ErigoBasic offers all basic functionalities to perform early and safe patient mobilization. With the ErigoPro, patient stimulation is additionally enhanced by the synchronized FES. The FES - stimulation controller RehaStim 2 generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. A connection cable enables the RehaStim 2 to receive the stimulation parameters from the ErigoPro control system. The electrode lead wires are used to connect ErigoPro-FES-Socket/RehaStim2 output and electrodes on skin. Every connected lead wire should connect to two electrodes (1 channel) for ErigoPro and 2x 4 channels for RehaStim2, respectively.
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    K Number
    K112844
    Device Name
    REHASTIM 2, REHAMOVE 2
    Manufacturer
    HASOMED GMBH
    Date Cleared
    2011-10-27

    (28 days)

    Product Code
    GZI, COM
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HASOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both the RehaMove 2 and RehaStim 2 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
    Device Description
    The RehaMove 2 is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser. The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes: active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser passive mode - only movement by motorized movement exerciser The FES – stimulation controller RehaStim 2 generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. A connection cable enables the RehaStim to receive angle-parameters and to control the Reck Viva II movement exerciser. Two electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connect the RehaStim 2 with the electrodes on the skin. A USB interface gives the possibility to connect the RehaStim 2 to the PC e.g. connect to patient database. The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
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    K Number
    K073237
    Device Name
    REHASTIM & REHAMOVE
    Manufacturer
    HASOMED GMBH
    Date Cleared
    2007-12-27

    (41 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    HASOMED GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both the RehaMove and RehaStim 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
    Device Description
    The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: (1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany (2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used (3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications. (4) an information cable (RS232) connects the RehaStim and the movement exerciser (5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin (6) an USB interface to connect the RehaStim to PC (7) The stand-alone mode of RehaStim allows training without movement exerciser. The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes: (1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser (2) passive mode only movement by motorized movement exerciser
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