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510(k) Data Aggregation
K Number
K241822Device Name
ReWalk® 7 Personal Exoskeleton (50-20-0005)
Manufacturer
ReWalk Robotics Ltd. DBA Lifeward
Date Cleared
2025-03-12
(261 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
ReWalk Robotics Ltd. DBA Lifeward
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReWalk® 7 Personal Exoskeleton fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions in home and community settings with supervision of a specially certified Companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in accordance with the User assessment and training certification program. The ReWalk 7 is intended for including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.
Device Description
The ReWalk® 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community.
Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints.
The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control.
All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use.
The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs.
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K Number
K221696Device Name
ReWalk P6.0
Manufacturer
ReWalk Robotics Ltd.
Date Cleared
2023-03-02
(265 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
ReWalk Robotics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReWalk® P6.0 fits to the lower limbs and part ofthe upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions in home and community settings with supervision of a specially certified companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk P6.0 is intended for indoor and outdoor use: including standing and walking on level surfaces and mild slopes and ascending and descending stairs and curbs.
Device Description
The ReWalk® P6.0 Exoskeleton is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame that fits to the lower limbs and part of the upper body.
The ReWalk is intended to enable certified users with spinal cord injuries at levels T7 to L5 to perform ambulatory functions in in home and community setting accompanied by a certified companion. Additionally, the ReWalk Personal Exoskeleton 6.0 is intended to enable certified users with spinal cord injuries at levels T4 to T6 to perform ambulatory functions in rehabilitation centers accompanied by a certified therapist.
Control of the device is achieved through a wrist-worn User-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI), and off the shelf crutches. All of the ReWalk components are mandatory, suitable for indoor and outdoor usage. The device is intended for indoor use: including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs for users who are at least 18 years old.
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K Number
K200032Device Name
ReWalk P6.0
Manufacturer
ReWalk Robotics Ltd.
Date Cleared
2020-05-26
(140 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
ReWalk Robotics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReWalk™ P6.0 orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
Device Description
The ReWalk™ P6.0 is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame fits to the lower limbs and part of the upper body. Control of the device is achieved through a wrist-worn user-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk™ P6.0 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI).
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K Number
K190337Device Name
ReWalk Restore
Manufacturer
ReWalk Robotics Ltd.
Date Cleared
2019-06-03
(109 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
ReWalk Robotics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.
Device Description
The ReWalk ReStore™ ("ReStore™") device is a lightweight, wearable, battery-powered soft orthotic exosuit is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
The ReStore™ device is designed to provide plantarflexion (PF) and dorsiflexion (DF) assistance to the paretic ankle during walking by transferring mechanical forces from two motors mounted on a Waistpack through Bowden cables to attachment points worn on the calf and insole. Through a set of gears, the motors actuate the Bowden cables to provide plantarflexion and dorsiflexion forces. Forces are transferred through the Bowden cables by pulling an inner cable within an outer sheath. The distal end of the outer sheath is fixed at an attachment point worn on the Calf Wrap, and the distal end of the inner cable is fixed at an attachment point worn on an insole made of flexible plastic that is worn within the shoe on the paretic foot. The relative motion that occurs between these two points when the inner cable is moved results in torques being applied across the ankle joint. The placement of the attachment points anterior and posterior to the ankle joint result in corresponding torques to provide assistance during dorsiflexion and plantarflexion, respectively. Load cells attached to the cables provide force feedback allowing control of the level of assistance provided to the patient. Sensors attached to the shoes are used to detect gait events during walking to inform timing of the assistance from the ReStore™ device. Specifically, inertial measurement units (IMUs) are attached to shoes on both legs to provide signals corresponding to events within the gait cycle, such as heel-strike or toeoff, in order to determine the appropriate timing of assistance from ReStore™.
The ReStore™ is designed to provide adjustable levels of assistance to the patient's paretic leg. It does not constrain or provide assistance to the patient's non-paretic leg. The device enables the therapist to individually modify the level of assistance provided during plantarand dorsiflexion as appropriate for each individual patient. The timing of assistance is based on data collected from the motion sensors on both the paretic and non-paretic feet, which determines the patient's orientation within their gait cycle.
Plantarflexion assistance occurs during the late stance and toe-off portion of the paretic leg gait cycle. This level of assistance targets a desired cable force, which can be adjusted from 0% to 25% of the patient's body weight. Dorsiflexion assistance occurs during the swing and heel-strike phase of the paretic gait cycle. This level of assistance targets a desired cable travel, which can be adjusted from 0 cm to 5 cm. Plantarflexion and dorsiflexion assistance levels are determined by the therapist based on visual evaluation of the patient's gait symmetry, the therapeutic goals of the walking session or the ability of the patient to achieve consistent ground clearance or heel-strike landing patterns with their paretic foot. The ReStore™ device includes apparel-like components, mechanical components, electrical components, cables, sensors and a handheld controller.
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