Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

K143690 · Ekso Bionics, Inc. · PHL · Apr 1, 2016 · Physical Medicine

Device Facts

• Record ID: K143690
• Device Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
• Applicant: Ekso Bionics, Inc.
• Product Code: PHL · Physical Medicine
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms: Individuals with hemiplegia due to stroke Individuals with spinal cord injuries at levels T4 to L5 Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D). The therapist must complete a training program prior to use of the devices are not intended for sports or stair climbing.

Device Story

Ekso is a powered motorized orthosis; consists of a fitted metal brace supporting legs, feet, and torso. Worn via straps; battery-powered motors drive knee and hip joints. Integrated solid torso contains computer and power supply. Operated by physical therapist using a handheld interface to specify settings and initiate steps; patient uses cane, crutch, or walker for stability. Used in rehabilitation institutions. Therapist monitors patient, selects programming, and manages safety. Device provides ambulatory function for patients with stroke or SCI; assists in sit-to-stand and walking. Benefits include rehabilitation mobility training. Failsafe feature: in power failure, knees lock and hips remain free to allow user to remain standing.

Clinical Evidence

Five clinical studies (total N=130+) evaluated safety and performance in SCI and stroke patients. Studies included prospective, open-label, and retrospective designs. Primary endpoints included 10-meter walk test (10MWT), 6-minute walk test (6MWT), and Functional Independence Measure (FIM). Results showed improvements in walking speed and distance post-training. Adverse events were minor (blisters, pain) and self-limiting; no falls reported in most cohorts. Clinical data supports safe use for ambulation and sit-to-stand transitions.

Technological Characteristics

Powered motorized orthosis; aluminum torso frame. Battery-powered (48.1V Li-ion, 30A peak). Adjustable hip, knee, and ankle joints. Handheld LCD controller. Connectivity: standalone. Electrical safety: IEC 60601-1:2005. EMC: IEC 60601-1-2:2007. Software: verification, validation, and hazard analysis performed.

Indications for Use

Indicated for adults >18 with hemiplegia due to stroke, or spinal cord injury (SCI) at levels T4-L5, or SCI at levels C7-T3 (ASIA D). Requires upper extremity motor function of at least 4/5 in both arms. Contraindicated 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

• ReWalk (K131798)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2016

Ekso Bionics. Inc. Thomas Looby President and Chief Commercial Officer 1414 Harbour Way South, Suite 1201 Richmond. CA 94804

Re: K143690

Trade/Device Name: Ekso™ (version 1.1) and Ekso GTTM (version 1.2) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 2, 2016 Received: March 2, 2016

Dear Mr. Looby:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143690

Device Name

EksoTM (version 1.1) and Ekso GTTM (version 1.2)

Indications for Use (Describe)

The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms:

· Individuals with hemiplegia due to stroke

· Individuals with spinal cord injuries at levels T4 to L5

· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D).

The therapist must complete a training program prior to use of the devices are not intended for sports or stair climbing.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#

| Device name | Ekso™ |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters name & contact info | Ekso Bionics® Inc.<br>1414 Harbour Way South<br>Suite 1201<br>Richmond, CA 94804 |
| | <b>Contact Details:</b><br>Thomas Looby<br>CEO |
| | Tel: [phone]<br>Email: [e-mail] |
| | Tel: [phone]<br>Fax: [phone] |
| Preparation Date | March 31, 2016 |
| Device Name & Classification | Trade Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)<br>Common Name: Exoskeleton<br>Classification Name: Powered Exoskeleton<br>Device Classification: Class II, 21 CFR 890.3480<br>Product Code: PHL |
| Indications for Use | The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms:<br><ul><li>Individuals with hemiplegia due to stroke</li><li>Individuals with spinal cord injuries at levels T4 to L5</li><li>Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D).</li></ul> The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |

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| Predicate Device | Manufacturer | 510(k) | Date |
|------------------|---------------------------|---------|-----------|
| | Argo Medical Technologies | K131798 | 6/26/2014 |

# Table 1- Comparison of Characteristics

| Manufacturer | Ekso Bionics®, Inc. | Argo Medical<br>Technologies, Inc. | Significant<br>Differences |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™<br>(version 1.2) | ReWalk™ | |
| 510(k) Number | K143690 | K131798 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Indications for Use | The Ekso™ (version<br>1.1) and Ekso GT™<br>(version 1.2) are<br>intended to perform<br>ambulatory functions<br>in rehabilitation<br>institutions under the<br>supervision of a<br>trained physical<br>therapist for the<br>following population<br>with upper extremity<br>motor function of at<br>least 4/5 in both<br>arms:Individuals with<br>hemiplegia due to<br>stroke, Individuals<br>with spinal cord<br>injuries at levels T4 to<br>L5, and Individuals<br>with spinal cord<br>injuries at levels of C7<br>to T3 (ASIA D). The<br>therapist must<br>complete a training<br>program prior to use<br>of the device. The<br>devices are not<br>intended for sports or<br>stair climbing. | The ARGO ReWalk™<br>orthotically fits to the<br>lower limbs and part<br>of the upper body and<br>is intended to enable<br>individuals with spinal<br>cord injury at levels<br>T7 to L5 to perform<br>ambulatory functions<br>with supervision of a<br>specially trained<br>companion in<br>accordance with the<br>user assessment and<br>training certification<br>program. The device<br>is also intended to<br>enable individuals<br>with spinal cord injury<br>at levels T4 to T6 to<br>perform ambulatory<br>functions in<br>rehabilitation<br>institutions in<br>accordance with the<br>user assessment and<br>training certification<br>program. The<br>ReWalk™ is not<br>intended for sports or<br>stair climbing. | Similar; the Ekso is<br>intended for stroke<br>and for a higher SCI<br>injury range for ASIA<br>D. No additional<br>safety or efficacy<br>concerns are<br>presented by the<br>additional indications. |
| Manufacturer | Ekso Bionics®, Inc. | Argo Medical<br>Technologies, Inc. | Significant<br>Differences |
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™<br>(version 1.2) | ReWalk™ | |
| Body Coverage | Worn over legs and<br>upper body with rigid<br>torso | Worn over legs and<br>upper body with<br>backpack | Similar; the<br>Ekso provides a rigid<br>back frame whereas<br>the predicate has a<br>separate backpack.<br>No additional safety<br>or efficacy concern as<br>the component<br>configuration is<br>similar for the legs,<br>hip, and torso of the<br>patient. |
| Size of Components | Adjustable upper leg,<br>lower leg, and hip<br>width; control unit<br>integrated into the<br>torso | Adjustable upper leg,<br>lower leg, and<br>multiple size pelvic<br>bands; with a<br>backpack control unit | Same |
| Mobility Aid | Walker, Crutches,<br>Cane | Crutches | Similar; both devices<br>utilize crutches as a<br>stability/mobility aid.<br>No additional safety<br>or efficacy concerns<br>are presented by<br>providing the added<br>mobility aid options<br>for the Ekso. |
| Ability of User<br>Mobility | Sit, stand, walk, and<br>turn | Sit, stand, walk, and<br>turn | Same |
| Walking Speed | ~2 km/hr | ~2 km/hr | Same |
| Grade of Inclination | 1.15 deg | 5 deg | Similar; the Ekso is<br>intended for flat<br>environments<br>whereas the<br>predicate is intended<br>for community<br>ambulation. No<br>additional safety<br>or efficacy concerns<br>are presented by the<br>lower grade. |
| Manufacturer | Ekso Bionics®, Inc. | Argo Medical<br>Technologies, Inc. | Significant<br>Differences |
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™<br>(version 1.2) | ReWalk™ | |
| Type of Surface | Smooth, cement,<br>carpet | Smooth, grass,<br>cement, carpet | Similar; the Ekso is<br>intended for indoor<br>environments and the<br>predicate is intended<br>for community<br>ambulation. The<br>Ekso not walking on<br>grass presents no<br>additional safety or<br>efficacy concerns. |
| Patient Population | Adults over age of 18<br>with hemiplegia due<br>to stroke, Spinal Cord<br>Injury (SCI) from T4<br>to L5, and SCI from<br>C7 to L5 ASIA D | Adults over age of 18<br>with Spinal Cord<br>Injury (SCI) from T4<br>to L5 | Different; the Ekso is<br>intended for stroke<br>and for a higher SCI<br>injury range for ASIA<br>D. Safety concern<br>associated with<br>higher level SCI and<br>stroke was evaluated<br>through clinical data<br>and indications for<br>use that limit use of<br>the device to patients<br>with adequate upper<br>extremity motor<br>strength in each<br>muscle group of at<br>least 4/5 in both arms |
| Height of Patient | ~62" to 74" (1.58 m to<br>1.88 m) | 63" to 75" (1.60 m to<br>1.90 m) | Similar; the Ekso can<br>fit one inch shorter<br>and one inch less<br>height and does not<br>present any<br>additional safety or<br>efficacy concern. |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface<br>for PT: weight shift to<br>initiate steps | Remote control worn<br>on the wrist to change<br>modes; postural cues<br>for stepping | Similar; both devices<br>require selection of<br>actions by the<br>controller. Ekso<br>initiates each step<br>separately based on<br>weight shift. No<br>additional safety or<br>efficacy concerns are<br>presented by the<br>Ekso method. |

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| Manufacturer | Ekso Bionics®, Inc. | Argo Medical<br>Technologies, Inc. | Significant<br>Differences |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™<br>(version 1.2) | ReWalk™ | |
| Range of Motion | Hips: 135° flexion to<br>20° extension<br>Knees: 130° flexion to<br>0° extension<br>Ankles: 10° flexion to<br>10° extension | Hips: 104° flexion to<br>34° extension<br>Knees: 112° flexion to<br>2° extension<br>Ankles: none | Similar; there is a<br>larger range of motion<br>for the Ekso to allow<br>easier sit-to stand<br>transitions and<br>greater comfort<br>during walking. No<br>additional safety or<br>efficacy concerns as<br>clinical data supports<br>the safe use of the<br>device for ambulation<br>and sitting/standing<br>transitions. |
| Weight | 50 lbs (23 kg) | 66 lbs. (30 kg) with 5<br>lbs.(2.3 kg) backpack | Different; Ekso is less<br>weight than the<br>predicate device; the<br>lessened weight of<br>the device does not<br>add any concern for<br>safety or efficacy. |
| Rechargeable Battery | Rechargeable lithium<br>ion batteries 48.1V,<br>30A peak current, 1<br>hour of continuous<br>usage per charge | Rechargeable lithium<br>ion primary with<br>lithium polymer<br>secondary.<br>25.9V, 30A peak<br>current, 10.4A<br>continuous current; 2<br>hours of continuous<br>walking per charge | Similar; the battery<br>types are slightly<br>different, but provide<br>the necessary power<br>for the operation of<br>the device. No<br>additional safety or<br>efficacy concern as<br>the battery power has<br>been tested per<br>specification. |
| Battery Charge Time | 1 hour | Minimum of 4 hours | Similar; the Ekso<br>batteries can be<br>recharged while<br>another set is in use.<br>No additional safety<br>or efficacy concerns<br>are presented by<br>Ekso's shorter<br>charge. |
| Expected Useable<br>Life | 4 years | 5 years | Similar; the Ekso is<br>expected to have a 4<br>year useable life. No<br>additional safety or<br>efficacy concerns are<br>presented by Ekso's<br>shorter life. |

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| Manufacturer | Ekso Bionics®, Inc. | Argo Medical<br>Technologies, Inc. | Significant<br>Differences |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™<br>(version 1.2) | ReWalk™ | |
| Training Program | Yes | Yes | Same |
| Certification Program | Yes | Yes | Same |
| User Feedback | Provides visual<br>feedback on the<br>handheld controller<br>and auditory<br>feedback | Provides vibratory<br>feedback from<br>backpack and LED<br>indicators on user's<br>wrist controller | Similar; both devices<br>use visual and other<br>feedback. No<br>additional safety or<br>efficacy concerns<br>from the auditory<br>feedback on the<br>Ekso. |
| Fall Detection and<br>Mitigation | None | None | Same |
| Failsafe Feature | In event of power<br>failure- knees<br>become locked and<br>hips free (similar to<br>typical passive leg<br>braces) | In the event of a<br>power failure the<br>ReWalk collapses<br>slowly whether user is<br>in safe condition for<br>sitting or not | Similar; the Ekso user<br>is allowed to remain<br>standing in the event<br>of a malfunction. No<br>additional safety or<br>efficacy concerns as<br>the failsafe features<br>allow the user to<br>recover during a fault<br>with the Ekso. |
| Operating<br>Temperature | 10° to 95°F (-12° to -<br>35° C) | -13°F to 105°F (-25°C<br>to 40°C) | Similar; the operating<br>temperature is similar<br>that would be<br>expected in a typical<br>setting for the use of<br>the device. |
| Operating Humidity | Not available | Not available | Same |
| Electrical Safety<br>Testing | IEC 60601-1:2005<br>with US deviations | IEC 60601-1:2005 | Same |
| Electromagnetic<br>Compatibility Testing | Passed IEC 60601-1-<br>2: 2007 | Passed IEC 60601-1-<br>2: 2007 | Same |

# Table 2 - Performance Testing

| Technical Area | Tests Completed |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety and<br>Electromagnetic<br>Compatibility | IEC 60601-1:2005, IEC 60601-1-2:2007, low battery testing, IEC<br>62133, IEC 61960 parts 7.4 and 7.5, UN 38.3, UN Manual<br>(ST/SG/AC. 10/11/Rev.5/Amend.1), battery life cycle testing |
| Durability | Worst case loading of knee and hip joints beyond service life,<br>worst case loading of structure beyond service life, ankle spring |

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| durability, component strength testing | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal | IEC 60601-1:2005 (ISO 7176 not required; batteries on the Ekso<br>are mounted to the aluminum Torso frame, enclosed in an<br>aluminum case, and not near any flammable material. The testing<br>conducted per IEC 60601 -1 in terms of flame retardant<br>evaluations is sufficient to support the device functionality in terms<br>of flame retardant materials.) |
| Software | Verification, Validation, and hazard analysis |
| Bench Testing | IEC 60601-1:2005 sec. 15.3 (IP22 not required) |

# Table 3 - Clinical Information

| Study | Description |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study 1 - SCI | Multi-center, prospective, open-label, non-comparative, non-randomized, prospective study of patients with spinal cord injury, at 6 sites from 5 countries<br>Duration of Intervention 27 visits over 12-13 weeks. 44 subjects total 35 ASIA A-B with injury levels from C7 to L2 21 ASIA C-D with injury levels from C1 to L2 32% female mean age of 39.9 years (range 19 to 65) mean time since injury 1146 days (range of 71 to 6790) Results Mean 10MWT pre and post-training were 66 (N=18) and 40 (N=7) seconds, respectively. Mean heart rates increased slightly from the pre-training measure to the mid-training measure while mean blood pressures remained stable. One (1) subject experienced a blister on the left shoulder under the backpack strap. Five (5) patients reported pain in the hands, lower back, or ribs. No falls were reported. All issues were self-limiting and resolved without medical attention. |
| Study 2 - SCI | Single center, open-label, non-comparative, non-randomized, prospective study of patients with spinal cord injury.<br>Duration of Intervention: 24 sessions over 12 weeks |
| | 12 subjects total 9 ASIA A with injury levels C7 to L1 3 ASIA B with injury levels T3 to T9 42% female mean age of 35 (range 19 to 56) mean time sine injury 7.6 years (range 1 to 24) |
| | Results Mean 10MWT pre and post-training were 160 (N=12) and 78 (N=17) seconds, respectively Mean 6MWT pre and post-training were 82 and 152 meters, respectively One (1) subject had 2 falls without injury. No injuries were reported |
| Study 3 - Stroke | Single center, exploratory retrospective analysis of patients with hemiplegia due to stroke |
| | Duration of Intervention Mean of 10 sessions (range 2 to 27) |
| | 54 subjects total used the Ekso GT Mean time since injury 12.2 days (range of 0 to 107 days) 36 ischemic, 18 hemorrhagic 7 moderate, 47 severe |
| | Results Mean 10MWT pre and post-training were 150 and 79 seconds, respectively Mean 6MWT pre and post-training were 40 and 88 meters, respectively Mean FIM scores pre and post-training were 24 and 49, respectively There were no falls or other adverse events reported |
| Study 4 - Stroke | Single center, open-label, non-comparative, non-randomized, prospective study of patients with hemiplegia due to stroke |
| | Duration of Intervention Mean of 3 sessions (range 1 to 9)…