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510(k) Data Aggregation
K Number
K024279Device Name
NESS CHILDREN SYSTEM
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2003-02-05
(44 days)
Product Code
IPG
Regulation Number
890.3025Why did this record match?
Product Code :
IPG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.
Device Description
The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.
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