Product Classification

• Device: stimulator, nerve, for restless legs syndrome
• Definition: An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
• Physical State: electrical stimulation unit with cutaneous electrodes
• Technical Method: applies electrical currents through electrodes on patient's skin
• Target Area: peroneal nerves
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: QWD
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 882.5887
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible