ARM
The ARM robot offers users an engaging and enjoyable approach to support their rehabilitation process.
UPPER-EXTREMITY
REHABILITATION TECHNOLOGY
PRODUCT OVERVIEW
Clinician-Supervised Movement, Assessment, and Structured Exercise
ARM is intended for upper-extremity isokinetic testing and evaluation in rehabilitation settings under clinician supervision. The system supports controlled mechanical movement for assessment, measurement, and clinician-directed exercise sessions.
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Non-invasive system design
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Controlled movement delivered through mechanical assistance and resistance
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Continuous clinician supervision during use
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No diagnosis or autonomous clinical decision-making
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Not life-sustaining and not life-supporting
ARM is being positioned under FDA Product Code IKK, 21 CFR 890.1925, “isokinetic testing and evaluation system,” a Class II device category currently listed as 510(k) exempt, subject to applicable limitations and general controls.
ARM Isokinetic Testing and Evaluation System
ARM is a clinician-supervised upper-extremity isokinetic testing and evaluation system designed for controlled movement, assessment, and clinician-directed exercise sessions in rehabilitation settings.
The system is non-invasive, operates through controlled mechanical motion, and is intended to support structured rehabilitation workflows while maintaining clinician oversight.
KEY FEATURES
Designed For Control, Consistency, and Supervised Use
DEFINED OPERATING LIMITS
System parameters are designed with defined limits for force, speed, and range of motion appropriate to the intended configuration and supervised use environment.
SAFETY INTERLOCKS
Multiple hardware and software safeguards are incorporated to support safe operation and controlled session management.
FAIL-SAFE ARCHITECTURE
Emergency stop and fail-safe mechanisms are included to support prompt interruption of movement when needed.
CLNICIAN-DEFINED OPERATION
Session parameters are configured by trained professionals. The system does not independently make clinical judgments.
REGULATORY AND QUALITY
Built With U.S. Market Entry in Mind
ARM is intended for upper-extremity isokinetic testing and evaluation in rehabilitation settings under clinician supervision. The system supports controlled mechanical movement for assessment, measurement, and clinician-directed exercise sessions.
510(k) exemption does not remove other FDA obligations. Prior to U.S. commercial distribution, applicable establishment registration, device listing, labeling, quality, and other regulatory requirements must still be completed and maintained.
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