Product Classification

• Device: stimulator, nerve, transcutaneous, for pain relief
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GZJ
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 882.5890
• 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

• 17-14 AAMI ANSI NS4:2013(R)2017
  Transcutaneous Electrical Nerve 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