Product Classification

• 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 Code: SDX
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); 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

Recognized Consensus Standard

• 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Third Party Review

Not Third Party Eligible