AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

The AGILIS is a multi-function physical therapy table available in three models (Plus, Pro, Basic) intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy through a motorized table with manual and electric operating systems. The device does not provide heat therapies and is designed for use by qualified healthcare professionals in physical medicine settings.

The proposed device uses 24Vdc electric motors to power traction, flexion, and lifting functions, whereas the predicate uses pneumatic actuators for the same functions. The AGILIS includes 6 manual drops (cervical, dorsal, lumbar, sacral, ankle) compared to the predicate's 5 pneumatic drops. Both devices feature emergency stop mechanisms, touchscreen controls, and automatic microprocessor-controlled cycles with configurable parameters. The proposed device has a visual alarm system versus the predicate's audible alarm.

EN/IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 for medical electrical equipment general requirements; IEC 60601-1-2:2014 + AMD1:2020 for electromagnetic compatibility. Bench performance testing included static and dynamic load application and functional analysis testing. The applicant followed FDA guidance on recommended non-clinical testing.

Both devices share identical indications for use, product code (JFB), regulatory classification (Class II), and intended patient population. The key technological difference—electric actuators instead of pneumatic—actually improves safety by eliminating dependence between actuator systems and preventing generalized failures that could cause unexpected movements. The additional ankle drop mechanism uses the same proven operating principle as existing cervical drops. All differences in dimensions, weight, alarm presentation, and control methods do not modify the known risks inherent to multi-function therapy tables. Electrical safety and electromagnetic compatibility testing demonstrates compliance with recognized standards equivalent to the predicate.