Product Classification

• Device: stimulator, muscle, powered, with limited output, for rehabilitation
• Regulation Description: Powered muscle stimulator.
• Definition: Used for muscle stimulation for rehabilitation. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area. Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• 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: NYY
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); 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