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
• Submission Type: 510(k)
• Regulation Number: 882.5890
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.