ReWalk® 7 Personal Exoskeleton (50-20-0005)

The ReWalk 7 Personal Exoskeleton is a wearable, battery-powered device that enables individuals with spinal cord injury (T7–L5 in home/community settings, T4–T6 in rehabilitation facilities) to stand and walk using motorized knee and hip joints controlled via a wireless wrist control unit or crutch-mounted control unit. It is intended for indoor and outdoor use on level surfaces, mild slopes, and stairs.

The ReWalk 7 replaces the predicate ReWalk P6.0's proprietary remote control with an off-the-shelf wireless wrist control unit (WCU) and adds an optional crutch-mounted control unit (CCU). It implements a new smart rechargeable lithium-ion battery following a recall, slightly increasing overall weight with negligible center-of-mass change. It also introduces pseudo-stand and pseudo-descent modes for stairs and adds a cloud-connected therapist handheld device (THD) for configuration instead of laptop-only maintenance.

IEC 60601-1-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 60601-1-11, IEC 62133-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, AAMI TIR69:2017, ISO 14971, AAMI TIR57:2016, IEC 80601-2-78, ASTM D4332-22, and ASTM D4169-22.

The ReWalk 7 maintains identical indications for use, contraindications, and basic operating principles as the predicate ReWalk P6.0. The enhancements (battery replacement, control unit upgrades, new operational modes, and connectivity features) focus on safety, user interface improvements, and device connectivity rather than altering the fundamental mechanism or intended use. Substantial equivalence testing confirmed that ReWalk 7 performs safely and effectively with the same performance characteristics as its predicate, demonstrating no new safety or effectiveness concerns.