Integrated Optical Sensing Robot System for Treating Patients with Upper Limb Functional Decline - Vietnam Registration 240000520/PCBB-HN
Access comprehensive regulatory information for Integrated Optical Sensing Robot System for Treating Patients with Upper Limb Functional Decline in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000520/PCBB-HN and manufactured by Idrogenet SRL. The authorized representative in Vietnam is CÔNG TY TNHH BÁCH KỲ PHƯƠNG.
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Device Details
Registration Details
240000520/PCBB-HN
000.00.19.H26-230703-0004
Gloreha Professional 2
Technical Details
Gloreha is a device designed to enhance the recovery of the motor function of the upper limb. It can passively move the joints of the hand-finger, the proximal and distal interphalangeal joints. These movements can be combined with visual and auditory stimuli. The patients can perform active movements, or perform movement exercises, through the on-screen guidance. Gloreha is a useful tool for therapists, to support them in their rehabilitation treatment activities for patients. Therapists can use Gloreha only after completing the training on the use of the device. Gloreha is indicated for the treatment of patients with mild and moderate hand paralysis after peripheral nerve injury or central nervous system injury (stroke, head trauma) or spinal cord injury. It is also indicated for the rehabilitation treatment and acute care of some conditions and procedures involving the hand joints, including: - Stiffness of the joints due to lack of movement after fracture fixation and dislocation; - Softening of the joints and reduction of stiffness after trauma to the hand-finger joints and interphalangeal joints; - Release surgery of the flexor tendons and extensor tendons of the fingers; - Hand or finger fusion surgery; - Dupuytren's contracture correction surgery; - Burns
Dates and Status
Mar 12, 2024

