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U.S. Department of Health and Human Services

Product Classification
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Device neuromuscular stimulator and exercise evaluation system
Definition A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.
Physical State Comprises a pulse generator, one or more sensors, and software to measure the evoked response
Technical Method Muscle stimulator plus one or more sensors that measure a physical or physiological response evoked by the stimulation
Target Area Peripheral muscles
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSDX
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.1871
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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