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The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES). The Indications for Use for the Shoulder PacemakerTM device are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults and adolescents age 14 and older.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies. The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies. The subject device can be used in stand-alone mode or in wireless mode. The Shoulder Pacemaker should be used in combination with: - conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation; - saver protection, interposed between the stimulator and the patient's arm. - The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation. The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES). The Indications for Use for Shoulder PacemakerTM are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies. The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies. The subject device can be used in stand-alone mode or in wireless mode. The Shoulder Pacemaker should be used in combination with: - conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation; - saver protection, interposed between the stimulator and the patient's arm. The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation. The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments. Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.

The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use. The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide. The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.

The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).

NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.