Product Classification

• Device: stimulator, electrical, transcutaneous, for arthritis
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Definition: Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
• Physical State: Electrical stimulation unit with leads and cutaneous electrodes.
• Technical Method: Applies an electrical current through electrodes on patient's skin.
• Target Area: Over or in proximity to affected joint.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: NYN
• 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

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