Product Classification

• Device: stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Definition: Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). 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 a patient's skin.
• Target Area: Electrodes are placed on the skin to stimulate nerves in proximity to the painful joint.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: OCF
• Premarket Review: Neuromodulation and Rehabilitation Devices (DHT5B); 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