ARM
The ARM robot offers users an engaging and enjoyable approach to support their rehabilitation process.
ABOUT US
Smart Machines Corp is a medical technology company founded in 2004 by Dr. Antonio Makiyama, PhD (University of Cambridge), with postdoctoral research at MIT. Dr. Makiyama has over two decades of experience in rehabilitation robotics in the United States and internationally and has led the design and development of multiple robotic systems for physical therapy and motor training.
The company specializes in robotic and electromechanical systems that support clinicians in delivering controlled, repeatable, and therapist-guided motor exercises. Smart Machines’ technologies are designed to enhance therapy consistency, safety, and efficiency while maintaining clinician oversight and patient engagement.
Smart Machines is advancing the ARM robotic rehabilitation system, a non-invasive device intended to support physical rehabilitation through guided motor exercise. ARM has been designed as a low-risk rehabilitation system and is being prepared for commercial launch in the first semester of 2026, following completion of applicable regulatory requirements.
Our Purpose
To be a global reference in rehabilitation technology by delivering safe, engaging, and effective solutions that support recovery in patients with orthopedic and motor impairments.
REHABILITATION ROBOT
The ARM robotic rehabilitation system is intended to support physical rehabilitation by providing controlled, therapist-prescribed motor exercises.
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Is non-invasive
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Provides assistance exclusively through controlled mechanical motion
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Operates under continuous clinician supervision
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Does not perform diagnosis, autonomous clinical decision-making, or life-sustaining functions
Based on its intended use, technological characteristics, and risk profile, ARM aligns with established FDA classifications for therapeutic exercise and physical rehabilitation devices regulated as Class II medical devices that are exempt from premarket notification (510(k)), while remaining subject to applicable General Controls.
Low-Risk Design Principles
ARM has been intentionally engineered in accordance with FDA expectations for low-risk rehabilitation devices, incorporating:
Defined limits on force, speed, and range of motion
Multiple hardware and software safety interlocks
Emergency stop and fail-safe mechanisms
Therapist-defined treatment parameters and protocols
No autonomous clinical decision-making functions
These design characteristics are consistent with those of FDA-regulated rehabilitation exercise devices currently marketed in the United States.
OUR BOARD TEAM
DR. ANTONIO MASSATO
MAKIYAMA
Antonio Makiyama is an engineer educated at USP, Cambridge, and MIT, bringing expertise in robotics, materials resistance, and human–machine interaction.
OUR QUALITY SYSTEM
Smart Machines develops ARM in alignment with applicable regulatory and quality requirements, including:
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FDA Quality System Regulation (21 CFR Part 820)
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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 safety verification and validation
All development activities are documented to support regulatory oversight and U.S. market entry.
GET IN TOUCH
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