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510(k) Data Aggregation

    K Number
    K071666
    Device Name
    SLENDERTONE ENERVIVE, MODEL 561
    Manufacturer
    BIO-MEDICAL RESEARCH CORP.
    Date Cleared
    2008-03-12

    (268 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "EnerVive™" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "EnerVive™" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "EnerVive training programs are designed for injured or ailing muscles and it's use on such muscles is contraindicated. The "EnerVive™' electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that "EnerVive™ can impose on the stimulated muscles are able to improve or facilitate muscle performance. "EnerVive™ may therefore be considered a technique of muscle training.
    Device Description
    EnerVive™ is the latest product offering from Slendertone, a division of Bio-Medical Research Ltd. It is a portable two-channel; battery operated neuromuscular electronic stimulation system. The device uses the principles of Neuromuscular Electrical Nerve Stimulation (NMES) and is intended for over the counter use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. It is not intended as a therapy for any medical condition. The two channels may be operated independently when each lead wire is attached to the unit and to the supplied butterfly-shaped electrode pads. Detailed diagrams for correct pad placement are available as part of the instructions for use. EnerVive™ stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. EnerVive™ contains 6 programs for exercise warm-up, muscle performance improvement and exercise recovery. Included in the product pack are an ergonomically designed EnerVive™ control unit, 4 adhesive pads (2 pairs), 1 x 9 volt battery (6F22), a belt clip, 2 lead wires, travel pouch and instructions for use.
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    K Number
    K070142
    Device Name
    SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
    Manufacturer
    BIO-MEDICAL RESEARCH CORP.
    Date Cleared
    2007-03-23

    (66 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System from Slendertone is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes. Indications for used are as follows: System-Abs, Type 390, E10/X10 - The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. System-Shorts, Type 390, E20 - Strengthening, toning and firming of the bottom and thigh region.
    Device Description
    System-Abs and System-Shorts are the newest product offerings from Slendertone (division of Bio-Medical Research Ltd.). The products include an interchangeable, rechargeable handheld controller, which can be used with a garment from the System range, to exercise specific areas of the body. The System-Abs belt is used to exercise the abdominal muscles and the System-Shorts is used to exercise the bottom and thigh muscles. The overall product consists of a garment (shorts for System-Shorts and belt for System-Abs), control unit, a pack of adhesive backed gel based electrodes (6 for System-Shorts and 3 for System-Abs), battery charger and instruction manual. System is a two-channel EMS product and offers 7 programs to the user of the belt and 4 programs to users of the shorts. Electrodes are applied to the inner surface of the garment to cover the silver studs and the garment is fitted (sizing options are given for a best fit) using the hook and loop patches. Each System garment contains an ID chip, which is programmed to determine the different model types and treatment parameters and is connected to the electronic controller unit via a lead and connector. The control unit generates the required stimulation signals and the garment connects these signals to the skin electrodes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. There is no current passed from side to side. Because the user has no access to the wiring or connectors within the garment, he/she cannot alter the current path and so the possibilities for misuse are greatly reduced. The product cannot be used whilst in charge mode. Materials: (Belt): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Foam -- 100% Polyurethane (Shorts): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Non-Elastic Hook and Loop - 100% Polyethylene, Foam - 100% Polyurethane, Stitch String - 100% Nylon.
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