Product Classification

• Device: stimulator, nerve, electrial, percutaneous (pens), for pain relief
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Definition: Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain.Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: NHI
• 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 Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.