Product Classification

• Device: stimulator, neuromuscular, external functional
• Regulation Description: External functional neuromuscular stimulator.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GZI
• Premarket Review: Neuromodulation and Rehabilitation Devices (DHT5B); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 882.5810
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc