Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a powered orthosis with a computer and power supply, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

Yes

The device is intended to perform "ambulatory functions in rehabilitation institutions" for individuals with specific medical conditions (hemiplegia due to stroke, spinal cord injuries). Rehabilitation is a therapeutic activity, and the device assists in this process to improve physical function, which falls under the definition of a therapeutic device.

Diagnostic

No

The device is described as a powered motorized orthosis intended to perform ambulatory functions in rehabilitation. Its purpose is to assist in walking, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "powered motorized orthosis" consisting of a "fitted metal brace," "battery powered motors," and an "integrated solid torso containing the computer and power supply." This indicates significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Ekso™ and Ekso GT™ devices are not In Vitro Diagnostic (IVD) devices.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Ekso/Ekso GT Function: The Ekso and Ekso GT are powered motorized orthoses designed to assist with ambulatory functions (walking) in a rehabilitation setting. They are worn externally on the body and directly interact with the patient's physical movement.
Lack of Specimen Analysis: The description and intended use clearly indicate that these devices do not analyze any biological specimens. They are mechanical devices that aid in physical therapy.

Therefore, the Ekso and Ekso GT fall under the category of medical devices but not specifically In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 device. The devices are not intended for sports or stair climbing.

Product codes (comma separated list FDA assigned to the subject device)

PHL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

legs, feet, and torso

Indicated Patient Age Range

Adults over age of 18

Intended User / Care Setting

trained physical therapist / rehabilitation institutions

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)

Study 1 - SCI:

Study Type: Multi-center, prospective, open-label, non-comparative, non-randomized, prospective study
Sample Size: 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).
Key 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:

Study Type: Single center, open-label, non-comparative, non-randomized, prospective study
Sample Size: 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 since injury 7.6 years (range 1 to 24).
Key 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:

Study Type: Single center, exploratory retrospective analysis
Sample Size: 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.
Key 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:

Study Type: Single center, open-label, non-comparative, non-randomized, prospective study
Sample Size: 54 subjects total. Mean time since injury 25.1 days (range of 5 to 146 days). 41 ischemic, 13 hemorrhagic. 4 moderate, 50 severe.
Key Results: Mean FIM scores pre and post-training were 25 and 51, respectively. Mean blood pressure before and after session 1 was 131/80 and 128/81, respectively. Mean heart rate before and after session 1 was 79 and 85, respectively. There were no falls or other adverse events reported.

Study 5 - Stroke:

Study Type: Single center, prospective, two-arm study
Sample Size: 8 subjects total (6 subjects had between 25 and 27 sessions (Arm 1), 2 subjects had 18 sessions (Arm 2)). Mean time since injury 601 days (range of 333 to 1550 days). 7 ischemic, 1 hemorrhagic. All limited household ambulators at recruitment.
Key Results: Mean 10MWT pre and post-training were 76 and 37 seconds, respectively. Mean 6MWT pre and post-training were 48 and 83 meters, respectively. Mean blood pressure before and after session 10 was 126/77 and 130/70, respectively. Mean Heart rate before and after session 10 was 73 and 78, respectively. There were no falls or other adverse events reported.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Mean 10MWT (10 Meter Walk Test) pre and post-training (time in seconds)
Mean 6MWT (6 Minute Walk Test) pre and post-training (distance in meters)
Mean FIM scores pre and post-training
Mean heart rates pre and post-training
Mean blood pressures pre and post-training

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131798

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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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3

Device name	Ekso™
Submitters name & contact info	Ekso Bionics® Inc.
1414 Harbour Way South
Suite 1201
Richmond, CA 94804
	Contact Details:
Thomas Looby
CEO
	Tel: +1 937-838-0842
Email: tom@eksobionics.com
	Tel: +1 (510) 984-1761
Fax: +1 (510) 927-2647
Preparation Date	March 31, 2016
Device Name & Classification	Trade Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
Common Name: Exoskeleton
Classification Name: Powered Exoskeleton
Device Classification: Class II, 21 CFR 890.3480
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:
Individuals with hemiplegia due to strokeIndividuals with spinal cord injuries at levels T4 to L5Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D). 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.

4

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

Table 1- Comparison of Characteristics

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

5

6

7

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

8

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

Table 2 - Performance Testing

Technical Area	Tests Completed
Electrical Safety and
Electromagnetic
Compatibility	IEC 60601-1:2005, IEC 60601-1-2:2007, low battery testing, IEC
62133, IEC 61960 parts 7.4 and 7.5, UN 38.3, UN Manual
(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,
worst case loading of structure beyond service life, ankle spring

9

durability, component strength testing
Thermal	IEC 60601-1:2005 (ISO 7176 not required; batteries on the Ekso
are mounted to the aluminum Torso frame, enclosed in an
aluminum case, and not near any flammable material. The testing
conducted per IEC 60601 -1 in terms of flame retardant
evaluations is sufficient to support the device functionality in terms
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
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.
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)
	54 subjects total Mean time since injury 25.1 days (range of 5 to 146 days) 41 ischemic, 13 hemorrhagic 4 moderate, 50 severe
	Results Mean FIM scores pre and post-training were 25 and 51, respectively. Mean blood pressure before and after session 1 was 131/80 and 128/81, respectively. Mean heart rate before and after session 1 was 79 and 85, respectively. There were no falls or other adverse events reported

24 sessions over 12 weeks.

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Single center, prospective, two-arm study of patients with Study 5 - Stroke hemiplegia due to stroke

Duration of Intervention

. 6 subjects had between 25 and 27 sessions (Arm 1)
2 subjects had 18 sessions (Arm 2) .

8 subjects total

Mean time since injury 601 days (range of 333 to 1550 . days)
. 7 ischemic, 1 hemorrhagic
. All limited household ambulators at recruitment

Results

. Mean 10MWT pre and post-training were 76 and 37 seconds, respectively
. Mean 6MWT pre and post-training were 48 and 83 meters, respectively
. Mean blood pressure before and after session 10 was 126/77 and 130/70, respectively
Mean Heart rate before and after session 10 was 73 and 78, respectively
. There were no falls or other adverse events reported.

Training

The Ekso provides various dynamic programming options that enable the physical therapist to customize sessions for patients based on a wide array of clinical presentations. To ensure safe operation, certification training is required before a therapist may use the Ekso.

To optimize the integration of the technology, certification training takes place in two phases. The training program is offered for up to 4 therapists from each facility with each Ekso purchased.

Phase 1 – Initial Training Week

The first phase is a full week of training for each therapist on the basic feature set of the Ekso. During training a therapist will become competent to:

Screen, evaluate, and measure Patients
. Setup the Ekso
. Fit the Ekso to the Patient
Use the Safety Checklist
. Select and use the operating mode appropriate for the patient
. Safely guard and cue patient during operation of the Ekso
Use the LCD Controller
. Perform after secession physical checks

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When a therapist is determined to be at Level 1 by the Ekso Bionics Clinical Training Team, it means the therapist has demonstrated the competence to safely operate the Ekso when working with another therapist at Level 1 (or higher).

At Level 1, a therapist does not direct any other staff or team member to aid in operation of the Ekso. Two therapists are required to do the following.

screening appropriate patients for using the Ekso
. administering a walking session
selecting appropriate programming
. managing emergency situations.

lt is important for therapists at Level 1 to continue using the Ekso after the initial training week to build their skills and be prepared for the second phase of training. It is recommended that they achieve the following prior to beginning phase 2.

. Perform 3-5 new patient evaluations and screenings for use of the Ekso
Adjust the Ekso hardware and software for 15 to 20 Ekso walking sessions
Manage 15 to 20 walking sessions in the Ekso with both new and recurring patients,
Don and Doff the Ekso for 10 to 15 patient sessions
Manage Ekso safety features (requires a variable number of sessions)

Phase 2 – Advanced Features

The Ekso Bionics Training Team returns to complete the second phase of training after a period of continued use of the Ekso by therapists at Level 1. Phase two training lasts 2-3 days and incorporates the remaining features of Ekso, and expands the possibilities for clinical use.

To progress from Level 1 to Level 2, a therapist must demonstrate the following mastery safely and independently.

evaluating and screening appropriate persons for use of the Ekso
. directing all aspects of Ekso operation to support personnel
. device operation and selection of appropriate programming for an Ekso walking session
. managing emergency situations

At Level 2, a therapist independently operates the Ekso with support personnel of his or her choice, and is fully responsible for directing and running all aspects of the Ekso walking session. Level 2 Ekso therapists are also able to delegate appropriate (high level) patients to support personnel that they supervise and train on proper Ekso operation/spotting.

Statement of Substantial Equivalence

Based on safety and performance testing, technological characteristics, and clinical data, the Ekso has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.