Product Classification

• Device: electromagnetic stimulator for healthy muscle stimulation
• Regulation Description: Powered muscle stimulator.
• Definition: A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.
• Physical State: The device generally includes a magnetic stimulator, a stimulation coil, and other accessories.
• Technical Method: The device uses a magnetic coil to produce a time-varying magnetic field, which induces a secondary electric field in the targeted tissues, which, in turn, non-invasively, temporarily increases local blood flow and stimulates healthy muscles.
• Target Area: The device generally targets muscles of the arms, legs, back, and/or buttocks.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: SGT
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5850
• 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

• 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
• smo india
• third party review group, llc