"Health Insurance Coverage through Approval of Medical Device Class 3 Items"
Angel Robotics Co., Ltd., a wearable robot specialist company, announced that its wearable gait rehabilitation robot ‘Angellex M20’ (model numbers M20-A-3C, M20-B-3C, two types) recently obtained Class 3 medical device approval from the Ministry of Food and Drug Safety, marking the start of its coverage under health insurance.
The Health Insurance Review & Assessment Service has newly established selective coverage for robot-assisted gait training in stroke patients since February this year, with a patient co-payment rate of 50% and an evaluation cycle of 5 years. The devices covered are limited to ‘robot-assisted orthotic exercise devices (Class 3, item number A67080.01)’ according to the Ministry of Food and Drug Safety’s ‘Regulations on Medical Device Items and Their Classification’.
Robot-assisted rehabilitation training is receiving significant attention in clinical practice because it allows repetitive treatment of the same intensity and provides measurable feedback. Due to the selective coverage of robot rehabilitation treatment, many medical institutions are actively considering its introduction.
The ‘Angellex M20’ that received this item approval is particularly notable for being the first wearable gait rehabilitation robot to be included in the health insurance reimbursement target.
Angel Robotics Co., Ltd., established in 2017, is a specialist company in rehabilitation and healthcare wearable robots. It has developed various wearable robots by combining robotics and ergonomics technologies. In particular, the ‘Angellex M20’ is a wearable gait rehabilitation robot used for patients or disabled individuals with gait disorders, aiming at lower limb muscle reconstruction and joint movement recovery. Unlike conventional robot rehabilitation that moves only along a trajectory inputted into the robot on a treadmill, this device uses an ‘overground method’ where the patient moves independently and trains with a therapist on flat ground, stairs, and squat modes. It provides assistive force according to the wearer’s movement intention, enabling active participation in training and is evaluated to have high rehabilitation training effectiveness.
The ‘Angellex M20’ has been distributed to more than 30 hospitals and welfare centers nationwide, starting with Sinchon Severance Rehabilitation Hospital. With the acquisition of Class 3 item approval, it is expected that more hospitals will actively adopt it as it becomes eligible for medical insurance reimbursement benefits.
Angel Robotics’ co-founders, CEO Kyungchul Gong (Professor of Mechanical Engineering at KAIST) and Vice CEO Dongwook Na (Professor of Rehabilitation Medicine at Yonsei University College of Medicine), stated, “The acquisition of Class 3 item approval is recognized as a result of continuous R&D investment in the development of gait rehabilitation robots, confirming quality and safety.” They added, “With the application of robot medical fees following this approval, we expect it to serve as a driving force for market expansion and sales growth.”
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