ReWalk Restore

K190337 · Re Walk Robotics , Ltd. · PHL · Jun 3, 2019 · Physical Medicine

Device Facts

• Record ID: K190337
• Device Name: ReWalk Restore
• Applicant: Re Walk Robotics , Ltd.
• Product Code: PHL · Physical Medicine
• Decision Date: Jun 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ReWalk ReStore 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 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 Story

ReWalk ReStore is a lightweight, wearable, battery-powered soft orthotic exosuit for rehabilitation. It assists paretic ankle plantarflexion and dorsiflexion during walking. Input: gait events detected by inertial measurement units (IMUs) on both feet. Transformation: motors in a waistpack actuate Bowden cables connected to a calf wrap and insole; load cells provide force feedback. Output: mechanical torque applied to the ankle. Used in rehabilitation institutions under therapist supervision. Therapist uses a handheld controller to adjust assistance levels (0-25% body weight for plantarflexion; 0-5cm cable travel for dorsiflexion) based on gait symmetry and therapeutic goals. Benefits: facilitates gait training, potentially increasing walking speed and distance for stroke patients.

Clinical Evidence

Clinical evidence includes a 44-subject multisite trial and engineering studies (total 79 subjects, 740 visits). Primary endpoint: safety (device-related adverse events/falls). Results: zero device-related serious adverse events or falls. Exploratory efficacy: 86.1% of subjects increased comfortable walking speed and 80.6% increased maximal walking speed with the device. Average 2-minute walk distance increased by 47.9 ft in Assist mode vs. Slack mode.

Technological Characteristics

Soft orthotic exosuit; textile frame/strapping; battery-powered motors/gears; Bowden cable actuation. Sensors: IMUs on shoes, load cells on cables. Connectivity: Bluetooth Low Energy (2.4 GHz) for handheld controller. Electrical safety: ANSI/AAMI ES60601-1. EMC: IEC 60601-1-2. Biocompatibility: ISO 10993-1/5/10. Modes: Assist, Slack, Brace.

Indications for Use

Indicated for individuals with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with minimal to moderate assistance. Not for sports or stair climbing.

Regulatory Classification

Identification

A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.

Special Controls

In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) Design characteristics must ensure geometry and materials composition are consistent with intended use. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; (ii) Simulated use testing ( *i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present; (iv) The accuracy of device features and safeguards; and (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. (6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: (i) Level of supervision necessary, and (ii) Environment of use ( *e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use. (8) Labeling for the Physician and User must include the following: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk. (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations; (B) Instructions on fitting the patient; (C) Instructions and explanations of all available programs and how to program the device; (D) Instructions and explanation of all controls, input, and outputs; (E) Instructions on all available modes or states of the device; (F) Instructions on all safety features of the device; and (G) Instructions for properly maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness. (iv) Pertinent non-clinical testing information ( *e.g.,* EMC, battery longevity).(v) A detailed summary of the clinical testing including: (A) Adverse events encountered under use conditions, (B) Summary of study outcomes and endpoints, and (C) Information pertinent to use of the device including the conditions under which the device was studied ( *e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain).

Predicate Devices

• Indego® (K173530)

Submission Summary (Full Text)

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June 3, 2019

ReWalk Robotics Ltd. Ofir Koren General Manager, VP R&D and Regulatory Affairs 3 Hetnufa St., POB Box- 161 Yokneam, 2069203 Israel

Re: K190337

Trade/Device Name: ReWalk Restore Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 4, 2019 Received: March 5, 2019

Dear Ofir Koren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190337

Device Name ReWalk Restore

### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <table style="border:none;"><tr><td><span style="font-size:120%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:120%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size:120%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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Image /page/3/Picture/0 description: The image is a logo for ReWalk Robotics. The logo has the word "ReWalk" in a combination of gray and yellow. Below the word "ReWalk" is the word "Robotics" in gray with a series of horizontal lines to the left of the word.

# ReStore™ 510(k) Summary

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Image /page/4/Picture/0 description: The image shows the ReWalk Robotics logo. The logo features the word "ReWalk" in a bold, stylized font, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller, gray font with lines to the left of the word. The logo is clean and modern, reflecting the company's focus on innovative robotic solutions.

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92

#### 1. Submission Sponsor

ReWalk Robotics Ltd. 3 Hatnufa St. Yokneam, Israel 2069203. POB: 161 Establishment Registration: 3007615665

#### 2. Submission Correspondent

Ofir Koren, General Manager, VP R&D and Regulatory Affairs

Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### 3. Date Prepared:

June 3, 2019

#### 4. Device Identification

| Name of Device: | ReWalk ReStore™ |
|------------------------------|---------------------|
| Classification Name: | Powered Exoskeleton |
| Regulation: | 21 CFR §890.3480 |
| Regulatory Class: | Class II |
| Product Classification Code: | PHL |
| Classification panel: | Neurology |

#### ട്. Legally Marketed Predicate Device

| Predicate Manufacturer: | Parker Hannifin Corporation |
|-------------------------|-----------------------------|
| Predicate Trade Name: | Indego® |
| Predicate 510(k): | K173530 |

#### 6. 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

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Image /page/5/Picture/0 description: The image contains the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller font size and gray color. There are also some gray lines below the word "ReWalk".

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.

| Mode Name | Mode Description |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assist Mode<br>(dynamic ankle<br>assistance) | A mode in which the cables provide assistance for ankle plantar and dorsiflexion during forward walking on level ground (treadmill or over ground). The level of assistance provided by the device can be adjusted by the therapist. |
| Slack Mode<br>(no assistance) | A mode in which the cables are positioned so as to not provide any resistance to movement by the subject during his/her full range of movement. |
| Brace Mode<br>(fixed ankle<br>position) | A mode in which the cables are retracted in a configuration that restricts the ankle movement in the plantar and/or dorsiflexion directions to maintain ankle position. |

Table 1: (System Modes)

During treadmill walking with ReStore™ in Slack Mode, no assistance is provided by ReStore. Patients should be evaluated for their baseline treadmill walking ability, and overhead harnessing, body weight support, or the integrated ReStore™ Support Handle should be used for safety if determined appropriate by the therapist.

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Image /page/6/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo has the word "ReWalk" in large letters, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in smaller letters. There are also some gray lines below the word "ReWalk".

#### 7. Intended Use / Indication for Use

The ReWalk ReStore 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 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.

#### 8. Substantial Equivalence Discussion

The following table compares the ReStore™ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices in Table 2 below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new or different questions of safety or effectiveness based on the similarities to the predicate device.

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Image /page/7/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo has the word "ReWalk" in large letters, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in smaller letters. There are also some gray lines below the word "ReWalk".

| Table 2: (Substantial Equivalence Discussion) | | | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Parker Hannifin Corporation<br>Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| 510(k) number | K173530 | K190337 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Regulation No. | 890.3480 | 890.3480 | Same |
| Indication for Use | The Indego® orthotically fits to the<br>lower limbs and trunk. The device is<br>intended to enable individuals with<br>spinal cord injury at levels T3 to L5<br>to perform ambulatory functions with<br>supervision of a specially trained<br>companion in accordance with the<br>user assessment and training<br>certification program. The device is<br>also intended to enable individuals<br>with spinal cord injury at levels C7 to<br>L5 to perform ambulatory functions<br>in rehabilitation institutions in<br>accordance with the user assessment<br>and training certification program.<br>Finally, the Indego® is also intended<br>to enable individuals with hemiplegia<br>(with motor function of 4/5 in least<br>one upper extremity) due to<br>cerebrovascular accident (CVA) to<br>perform ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user assessment<br>and training certification program.<br>The Indego is not intended for sports<br>or stair climbing. | The ReWalk ReStore is intended to be used to<br>assist ambulatory functions in rehabilitation<br>institutions under the supervision of a trained<br>therapist for people with hemiplegia/<br>hemiparesis due to stroke who can ambulate at<br>least 1.5m (5ft) with no more than minimal to<br>moderate levels of assistance. The trained<br>therapist must successfully complete a training<br>program prior to operating the device. The<br>device is not intended for sports or stair<br>climbing. | Comparable -<br>The intended use of enabling individuals to perform<br>ambulatory functions in rehabilitation institutions is<br>the same.<br>Indego® has broader indications, namely for<br>individuals with spinal cord injury in addition to<br>individuals with hemiplegia (with motor function of<br>4/5 in least one upper extremity) due to<br>cerebrovascular accident (CVA).<br>The ReStore™ indications are a subset of these<br>indications (individuals with hemiplegia due to<br>stroke).<br>This difference does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Characteristic | Parker Hannifin Corporation<br>Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Patient Population | Individuals with hemiplegia (with<br>motor function of 4/5 in at least one<br>upper extremity) due to<br>cerebrovascular accident (CVA) | Individuals with hemiplegia / hemiparesis due<br>to stroke | Similar –<br>Both devices are indicated for use by individuals<br>with hemiplegia (hemiparesis which is subset of<br>Hemiplegia is also included in ReStore™).<br><br>ReStore™ does not require use of upper extremity<br>mobility aids. Indego® inherently requires use of<br>mobility aides like crutches for support, and thus<br>requires motor function of 4/5 in at least one upper<br>extremity.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Device<br>construction and<br>materials | The Indego® device is composed of<br>rigid frame and textile strapping<br>providing body weight support to the<br>patient | ReStore™ device is composed of textile frame<br>and strapping worn by patient | Different –<br>ReStore™ provides the ankle joint with assistance<br>without supporting the patient, while the Indego®<br>provides assistance within a rigid body supporting<br>frame.<br>Both frames enable transfer of mechanical forces<br>from motors and gears (based on data obtained<br>from sensors) to the wearer.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Body Coverage | Worn over legs and around hips and<br>lower torso | Worn over legs and around lower torso | Similar –<br>ReStore™ provides assistance to paretic ankle<br>joint, while Indego® provides assistance to knee<br>and hip joints, thus the difference in body coverage.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Characteristic | Parker Hannifin Corporation<br>Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Size of<br>Components | Modular small, medium and large<br>upper leg, lower leg and hip<br>components and control unit<br>integrated into hip unit | Modular small, medium, large and extra-large<br>paretic leg component, control unit<br>(waistpack) integrated into adjustable waist<br>belt | Similar -<br>Both devices utilize similar component sizes.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Mobility Aid | Walker, cane or crutches | Walker, cane, crutches, harness or overhead<br>support | Similar -<br>Mobility aides are required for use of Indego®. Use<br>of mobility aides for ReStore™ is per therapist<br>discretion.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Ability of User<br>Mobility | Sit, stand, walk and turn | Sit, stand, walk and turn | Same |
| Walking Speed | ~2 km/hr. | Up to 5km/hr. | Different -<br>Both devices utilize upper limit for walking speed.<br>The ReStore™ maximum supported speed is<br>higher, however the gait algorithm provides<br>consistent force and timing profiles to support<br>wearer's natural walking speed.<br>This difference does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Type of Surface | Smooth, grass, cement, carpet,<br>transitions, thresholds | In the clinical trial ReStore™ was tested under<br>the following conditions:<br>Treadmill: Assist Mode<br>Level Indoor Floor: All modes (Assist, Brace,<br>and Slack mode) | Different -<br>ReStore™ can be used on treadmills as well.<br>The device can be used on indoor only, on surfaces<br>including carpeting and hard floors or even<br>surfaces.<br>This difference does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Characteristic | Parker Hannifin Corporation<br>Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Control Method | Uses postural cues and user motion to<br>trigger all transitions | Uses patient gait motion to trigger assistance | Similar -<br>Both devices are activated by user motion.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Patient<br>height/weight | 61" to 75" (155 to 191 cm)<br>Up to 250 lbs. (113kg) | 56" to 75.5" (142 to 192cm)<br>Up to 264 lbs. (120kg) | Similar -<br>Both devices support similar range of height/weight<br>of patient.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Range of Motion | Hip: 110° flexion to 30° extension<br>Knee: 110° flexion to 10° extension | Axial forces applied to the ankle joint<br>corresponding to wearer's ankle joint range of<br>motion | Similar -<br>Both devices utilize assistance to the patient gait<br>cycle by allowing movement within the joint's<br>range of motion.<br>This similarity does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Use environment | Rehabilitation institutions | Rehabilitation institutions | Same |
| Device weight | 26 lbs. (11.6 kg) | 11 lbs. (5 kg) | Different -<br>ReStore™ weighs less than the Indego® device.<br>The relatively low weight of the ReStore™<br>minimally affects the patient's balance.<br>This difference does not raise any new or different<br>questions of safety or effectiveness, as is<br>demonstrated by clinical data. |
| Rechargeable<br>Battery | Rechargeable lithium ion.<br>33.3 V, 36A peak current, 12A<br>continuous current.<br>159Wh fully charged; 1.5 hours of<br>continuous walking fully charged | Two off-the-shelf rechargeable lithium ion<br>batteries: 15.0 VDC x 2<br>(total voltage = 30 VDC)<br>3.2 AH, 48Wh. Minimum 2 hours continuous<br>walking fully charged | Similar -<br>Both devices utilize the same battery technology<br>and provide similar use duration. |
| Characteristic | Parker Hannifin Corporation<br>Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Battery Charge<br>Time | Maximum of 4 hours…