Product Classification

• Device: stimulator, electrical, transcutaneous, with limited output, for aesthetic purposes
• Regulation Description: Transcutaneous electrical nerve stimulator for pain relief.
• Definition: Electrical stimulation for aesthetic purposes
• Physical State: Electrical stimulation unit with leads and cutaneous electrodes
• Technical Method: Electrical stimulation using current applied to electrodes on a patient's skin
• Target Area: Electrodes are placed on the skin in proximity to the area of interest
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: NYX
• 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