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Device Interactive Rehabilitation Exercise Device, Prescription Use
Regulation Description Measuring exercise equipment. Definition A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform. Physical State The device employs sensors, a camera, and a screen to track user movement and provide visual feedback. Technical Method The device employs sensors, a camera, and a screen to track user movement and provide visual feedback. Target Area The device targets the limbs, trunk, and joints. Regulation Medical Specialty Physical Medicine Review Panel Physical Medicine Product Code QKC Premarket Review Office of Neurological and Physical Medicine Devices6 (OHT5) Neuromodulation and Rehabilitation Devices (DHT5B) Submission Type 510(K) Exempt Regulation Number 890.53607 Device Class 2 Total Product Life Cycle (TPLC) TPLC Product Code Report8 GMP Exempt? No Summary Malfunction Ineligible Reporting Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices9 subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. Implanted Device? No Life-Sustain/Support Device? No Third Party Review Not Third Party Eligible
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