OPP003 📄 Overview A wearable SaMD (e.g., smart sleeve, specialized vest, or glove) that integrates advanced haptic feedback with motion sensors (IMUs) and an accompanying application. For rehabilitation, it provides real-time, tactile guidance for correct exercise form, proprioceptive training, and range-of-motion limits. For pain management, it delivers programmed haptic stimulation (e.g., precise vibrations, pressure modulation) to specific areas, acting as a non-pharmacological analgesic or distraction therapy. The application tracks progress, allows for clinician remote adjustments, and provides data for RWE generation. Key technologies: 👤 Target users: 👍 Benefits Improved adherence to rehabilitation protocols • Enhanced motor learning and recovery outcomes • Non-opioid alternative for pain management • Enables effective remote physical therapy • Objective measurement of movement quality and progress Use bullets or new lines. 👎 Challenges Miniaturization and user comfort for continuous wear • Battery life for haptic actuators • Clinical validation of haptic efficacy for specific conditions • Cost-effectiveness and reimbursement for devices with integrated therapy • Scalability of haptic experiences for varied body types and conditions 📋 Regulatory & Validation Likely Class II SaMD for therapeutic claims and Class I/II for hardware components • Specific performance standards for haptic output and safety • Data privacy for motion and biofeedback data