Product Classification

• Device: stimulator, muscle, diagnostic
• Regulation Description: Diagnostic muscle stimulator.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: ISB
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.1850
• 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

• 17-20 IEC 60601-2-40 Third edition 2024-12
  Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• smo india
• third party review group, llc