(261 days)
Not Found
No
The document describes a device controlled by user input (wrist/crutch units, body movements via tilt sensor) and powered by motors. There is no mention of AI, ML, or any learning or adaptive algorithms in the control system description or performance studies.
Yes
The device is intended to enable individuals with spinal cord injury to perform ambulatory functions, which directly addresses a medical condition to improve physical function and quality of life.
No
Explanation: The ReWalk® 7 Personal Exoskeleton is described as a device to enable individuals with spinal cord injury to perform ambulatory functions (standing and walking). Its function is to assist with movement, not to diagnose a condition.
No
The device description explicitly details hardware components such as rigid frames, waist pack, straps, battery power supply, crutches with integrated powered control units, a wrist control unit, gears, and motors. It is a physical exoskeleton with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ReWalk 7 Personal Exoskeleton is designed to enable individuals with spinal cord injury to perform ambulatory functions (standing and walking). This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a wearable, battery-powered exoskeleton with mechanical components (gears, motors) and control units. This aligns with a physical assistance device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on biological samples.
The ReWalk 7 is a medical device, but it falls under a different classification than IVDs. It is a device that provides physical support and assistance for mobility.
N/A
Intended Use / Indications for 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 indoor and outdoor use: including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.
Product codes
PHL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs and part of the upper body
Indicated Patient Age Range
at least 18 years old
Intended User / Care Setting
certified individuals; home and community settings with supervision of a specially certified Companion; rehabilitation institutions; certified therapists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To evaluate the performance and safety of the ReWalk 7, tests and analysis were executed according to accepted scientific methods, FDA applicable recognized consensus standards, guidance documents, and regulations including special controls in 21 CFR 890.3480.
The subject device operation and technical characteristics were tested and evaluated according to below applicable recognized standards:
· 60601-1 Edition 3.2 2020-08 consolidated version, Medical electrical equirements for basic safety and essential performance - Note: This standard is recognized with relevant US.
· IEC60601-1-2 Edition 4.1 2020-09 consolidated version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
· IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
· IEC 60601-1-11 Edition 2.1 2020-07 consolidated version O Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
· IEC 62133-2 Edition 1.0 2017-02, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
· IEC 60601-1-6 Edition 3.2 2020-07 consolidated version - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
· IEC 62366-1 Edition 1.1 2020-06 consolidated version, Medical devices - Part 1: Application of usability engineering to medical devices.
· IEC 62304 Edition 1.1 2015-06 consolidated version Medical device software - Software life cycle processes.
• ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
· AAM TIR69:2017/(R2020), Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
• ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices · AAMI TIR57:2016, Principles for medical device security - Risk management.
· IEC 80601-2-78 Edition 1.0 2019-07, Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation assessment compensation or alleviation
· ASTM D4332-22 Standard Practice for Performance Testing of Shipping Containers and Systems
· ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
Clinical tests were not required as the device's indication for use, indications and contraindications are identical to predicate device.
To evaluate the performance and safety of the ReWalk 7, tests and analysis were executed according to accepted scientific methods, FDA applicable recognized consensus standards, guidance documents, and regulations including special controls in 21 CFR 890.3480, demonstrated that ReWalk 7 performs safely and effectively according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3480 Powered lower extremity exoskeleton.
(a)
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.(b)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2025
ReWalk Robotics Ltd. DBA Lifeward Pariente Miri VP of QA, RA and Operations 3 Hatnufa St., P.O Box 161 Yokneam Ilit, 2069203 Israel
Re: K241822
Trade/Device Name: ReWalk® 7 Personal Exoskeleton (50-20-0005) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: June 23, 2024 Received: June 24, 2024
Dear Pariente Miri:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ReWalk® 7 Personal Exoskeleton (50-20-0005)
Indications for Use (Describe)
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 perform ambulatory functions in rehabilitation institutions in accordance with the User assessment and training certification program. The ReWalk 7 is intended for indoor and outdoor use: including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| 510(k) #: | K241822 | 510(k) Summary | Prepared on: 2025-02-13 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
21 CFR 807.92(a)(1)
| Contact Details | |
|---|---|
| Applicant Name | Lifeward LTD. |
| Applicant Address | 3 Hatnufa St., P.O Box 161 Yokneam Ilit 2069203 Israel |
| Applicant Contact Telephone | +972-58-5605090 |
| Applicant Contact | Mrs. Pariente Miri |
| Applicant Contact Email | miri.pariente@golifeward.com |
21 CFR 807.92(a)(2)
| Device Name | |
|---|---|
| Device Trade Name | ReWalk® 7 Personal Exoskeleton (50-20-0005) |
| Common Name | Powered lower extremity exoskeleton |
| Classification Name | Powered Exoskeleton |
| Regulation Number | 890.3480 |
| Product Code(s) | PHL |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221696 | ReWalk® P6.0 | PHL |
| K200032 | ReWalk® P6.0 | PHL |
| K160987 | ReWalk® P6.0 | PHL |
Device Description Summary
21 CFR 807.92(a)(4)
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.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
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
cordinjury at levels T7 to L5 to performambulatory 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
5
level surfaces and mild slopes, and ascending and descending stairs and curbs.
Indications for Use Comparison
The indication for use of the subject device and the predicate are identical.
Technological Comparison
This traditional 510(k) submission introduces the ReWalk 7 personal exoskeleton, an enhanced version of its predicate device, the ReWalk P6.0 (K221696). The ReWalk 7 is identical to the predicate device in terms of intended use, contraindications for use, indications, environment of use, intended users nad basic principles of operations. Importantly, the exoskeleton's structure remains unchanged.
The enhancement and refinements focus on device safety, improving user interfaces, and device connectivity:
-
Battery Spec Change: Implementation of off-the-shelf smart rechargeable Li-ion battery following the predicate Recall number-1553-2021, RES# 8781. To accommodate the battery change, the internal structure of the Main processing board (MPB) was changed and its overall weight increased due to the battery replacement following the recall. An analysis confirmed that this weight increase is negligible and does not alter the center of mass.
-
Off-the-shelf Wrist Control Unit (WCU), which remains the primary device controller, replaces the proprietary Remote Control (RC). Additionally, an optional Crutch Control Unit (CU) mounted on the existing right crutch was added, enabling users to control ReWalk exoskeleton modes (SIT, STAND, WALK FAST, ASCEND/DESCEND) without releasing their grip from the crutch.
-
System Modes of Operation - The system modes of operation have been updated in two ways: The existing Walk gait configuration has been split into two modes: Walk Slow. This change does not affect the speed range of the cleared device, and the gat settings are still preconfigured by a certified therapist. The new pseudo modes in ReWalk 7 introduce a pseudo-STAND mode for ascending and descending stairs and curbs.
Both changes are supported by an icon in the WCU for user convenience.
-
Therapist Means for Control: Introduction of an off-the-shelf cloud-connected Therapist Handheld Device (THD), instead of the laptop. Introduction of laptop only for maintenance activities executed by certified ReWalk technicians.
-
Device Connectivity: Introduction of a cloud server application tracking and maintenance transition to device proprietary wireless communication and improved cybersecurity.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
To evaluate the performance and safety of the ReWalk 7, tests and analysis were executed according to accepted scientific methods, FDA applicable recognized consensus standards, guidance documents, and regulations including special controls in 21 CFR 890.3480.
The subject device operation and technical characteristics were tested and evaluated according to below applicable recognized standards:
· 60601-1 Edition 3.2 2020-08 consolidated version, Medical electrical equirements for basic safety and essential performance - Note: This standard is recognized with relevant US.
· IEC60601-1-2 Edition 4.1 2020-09 consolidated version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
· IEC TR 60601-4-2 Edition 1.0 2016-05, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
· IEC 60601-1-11 Edition 2.1 2020-07 consolidated version O Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
· IEC 62133-2 Edition 1.0 2017-02, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
· IEC 60601-1-6 Edition 3.2 2020-07 consolidated version - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
· IEC 62366-1 Edition 1.1 2020-06 consolidated version, Medical devices - Part 1: Application of usability engineering to medical devices.
· IEC 62304 Edition 1.1 2015-06 consolidated version Medical device software - Software life cycle processes.
• ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
· AAM TIR69:2017/(R2020), Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
• ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices · AAMI TIR57:2016, Principles for medical device security - Risk management.
· IEC 80601-2-78 Edition 1.0 2019-07, Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation assessment compensation or alleviation
· ASTM D4332-22 Standard Practice for Performance Testing of Shipping Containers and Systems
· ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
Clinical tests were not required as the device's indication for use, indications and contraindications are identical to predicate device.
To evaluate the performance and safety of the ReWalk 7, tests and analysis were executed according to accepted scientific methods, FDA applicable recognized consensus standards, guidance documents, and regulations including special controls in 21 CFR 890.3480, demonstrated that ReWalk 7 performs safely and effectively according to its intended use.
The substantial equivalence analysis demonstrated that 7 and its predicate have an identical intended use, indication for use, indications , contraindication and basic principles of operations. The devices have similar technological characteristics such communication methods and operation modes.
Accepted scientific methods exist to evaluate the performance and safety of the ReWalk 7 compared to its Predicate Device, the ReWalk 7 Personal Exoskeleton device is substantially equivalent to the previously cleared ReWalk 7 Exoskeleton device demonstrated that it is as safe and effective as its Predicate.
Thus, it can be concluded that the safety and effectiveness of ReWalk 7 is the same as the predicate ReWalk P6.0 and does not raise different questions of safety and effectiveness .