ABOUT SMC
Engineering Focused on Controlled Rehabilitation Movement
Smart Machines Corporation develops robotic and electromechanical systems intended to support structured movement-related activities in rehabilitation environments, with emphasis on safety, consistency, and clinician supervision.
Company Overview
Smart Machines Corporation is a medical technology company founded in 2004 by Dr. Antonio Makiyama, PhD (University of Cambridge), with postdoctoral research at MIT. The company’s work includes robotic and electromechanical systems designed for structured movement and rehabilitation-related applications.
ARM is being prepared for U.S. market entry following completion of applicable regulatory, quality, registration, and listing requirements.
OUR TEAM
Our team is composed of highly experienced engineers totaling more than 70 years of experience in robotics and automation, combining strong technical expertise with a passion for innovation. Alongside them, we have a dedicated game design team with deep knowledge in developing interactive and engaging games specifically focused on rehabilitation and therapeutic applications.
By uniting advanced engineering with creative game development, we deliver intelligent, user-centered solutions that enhance performance, motivation, and real-world impact.
DESIGN PRINCIPLES
How A.R.M. is Positioned
CLINICIAN SUPERVISED USE
ARM is intended for use under clinician supervision in rehabilitation settings.
CLEAR SCOPE
The system does not perform diagnosis and does not make autonomous clinical decisions.
STRUCTURED MOVEMENT SUPORT
The system is designed for controlled mechanical movement, assessment, and clinician-directed exercise sessions.
REGULATORY ALIGNIMENT
ARM is being positioned under FDA Product Code IKK, 21 CFR 890.1925, within a Class II category currently listed as 510(k) exempt.
The final device configuration is intended to be developed and evaluated with consideration of applicable safety and essential-performance requirements for rehabilitation robots, including IEC 80601-2-78, as applicable.
Dr. Antonio Makiyama
LEADERSHIP
Antonio Makiyama is an engineer educated at USP, Cambridge, and MIT, with experience spanning robotics, materials resistance, and human-machine interaction. His work has focused on the development of electromechanical systems for rehabilitation and structured movement applications.
QUALITY POLICY
Development and compliance approach
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FDA Quality Management System Regulation (QMSR), 21 CFR Part 820
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ISO 13485:2016-aligned quality management processes
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Documented design controls, risk analysis, and traceability
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Risk management activities aligned with ISO 14971 principles
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Electrical, mechanical, and software verification and validation activities
NOTE
This website provides general product and company information. It does not constitute FDA clearance, approval, certification, or endorsement, and it should not be interpreted as making diagnostic or autonomous treatment claims.