Product Classification

• Device: stimulator, muscle, powered, with limited output, for muscle conditioning
• Regulation Description: Powered muscle stimulator.
• Definition: Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.
• Physical State: Electrical stimulation unit with leads and cutaneous electrodes
• Technical Method: Stimulation of muscles using electrical current applied to electrodes on a patient's skin
• Target Area: Electrodes are placed on the skin overlying the muscle or motor nerve to be stimulated
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: NYZ
• Premarket Review: Neuromodulation and Rehabilitation Devices (DHT5B); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5850
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 17-16 IEC 60601-2-10 Edition 2.1 2016-04
  Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc