Product Classification

• Device: stimulator, muscle, powered
• Regulation Description: Powered muscle stimulator.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: IPF
• 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