START here to begin the ReWalk screening process

Help identify eligible patients who can benefit from regular use of the ReWalk Personal Exoskeleton by Lifeward, the only exoskeleton with access to stairs & curb function. Medicare has now finalized its reimbursement for personal exoskeletons, enabling medically eligible beneficiaries to pursue the benefits of walking again with confidence and clarity in the reimbursement pathway. Our team is built to be your partner through the identification, screening, medical record collection, reimbursement process, and beyond – with dedicated Personal Care Team members for each step of the way.

The only personal exoskeleton with access to stairs and curbs

• Confidence —Regain a greater sense of control after spinal cord injury.
• Inclusion —Stand eye-to-eye with others and re-engage in social activities.
• Access —Regain walking access to everyday venues and terrains, including stairs and curbs.
• Frequency —Integrate into your daily activities for more opportunities to achieve the clinical benefits of walking.

Life-changing robotics The ReWalk Personal Exoskeleton provides powered hip and knee motion and adjustable ankle joints to enable individuals with spinal cord injury to stand upright and walk during activities of daily life in their home and community. It is the only personal exoskeleton FDA-cleared for use on stairs and curbs.¹

Proud supporter of the U.S. Department of Veterans Affairs

 

References

1. FDA clearance letter K221696, dated March 3, 2023
2. Gorman et al., J Clin Med (2021)
3. Duddy et al., Sensors (2021)
4. Shackleton et al., J Rehab Med (2019)
5. Juszczak et al., Topics Spin Cord Inj Rehab (2018)
6. ReWalk user survey, 2022 N=41

ReWalk Important Safety Information

INDICATION

The ReWalk® P6.0 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 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.

• Spinal cord injury at levels T7 − L5
• Hands and shoulders can support crutches or a walker
• Healthy bone density, meaning sufficient bone density according to the judgement of the prescribing physician after clinical examination of the patient —including radiological proof, if needed
• Skeleton does not suffer from any fractures
• In generally good health
• Height is between 160 cm and 190 cm (5′ 3″ – 6′ 2″)
• Weight does not exceed 100 kg (220 lb.)
• At least 18 years old

CONTRAINDICATIONS

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI, etc.)
• Severe concurrent medical conditions that would interfere with safe device use or walking
• Uncorrectable Equinovarus foot deformation
• Severe spasticity (Modified Ashworth 4)
• Unable to tolerate standing position in a supported standing device
• Amputations and lower limb prostheses
• Unstable or unhealed fractures of the spine, pelvis and/or lower extremities
• Uncorrectable leg length discrepancy over 2 cm when using additional correction tools
• Heterotopic ossification that impair joint mobility
• Significant arthritis or contractures that limit lower limb range of motion necessary for adequate walking
• Psychiatric or cognitive disorders that may interfere with proper operation of the device
• Pregnancy

WARNINGS & PRECAUTIONS

• The user must be trained to use the ReWalk™. Use of the device without training can result in serious injury
• Use of the device without fitting and customizing can result in serious injury
• Battery malfunctions – such as current leakage, electrical shock during charging, battery overheating, excessive charging current, etc. – can result in serious injury
• Do not attempt to use the device if a software malfunction has caused a total loss of functionality or if there is a general mechanical failure
• Using the device on irregular surfaces could result in loss of balance and possible injury
• The device is designed for use with crutches.
• Changes or modifications not expressly approved by ReWalk Robotics Ltd. can affect the safety and effectiveness of the device and will void the system’s warranty

PREGNANCY

There are no adequate data on the risks associated with the use of the ReWalk® P6.0 by pregnant women

ADVERSE EVENTS

The most common reportable adverse event (AE) that occurs, in less than 4% of ReWalk users, is appendicular fracture

To report suspected adverse events, contact Lifeward at 1-508-251-1154 or FDA at 1-888-INFO-FDA or www.fda.gov/medwatch