Indego

K152416 · Parker Hannifin Corporation · PHL · Feb 26, 2016 · Physical Medicine

Device Facts

• Record ID: K152416
• Device Name: Indego
• Applicant: Parker Hannifin Corporation
• Product Code: PHL · Physical Medicine
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Indego® orthotically fits to the lower limbs and the trunk; the device 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 Indego is not intended for sports or stair climbing.

Device Story

Wearable powered exoskeleton; assists standing and walking for SCI patients. Comprised of 5 modular components (lumbar/hip, bilateral upper/lower legs); total weight 26 lbs. Hip unit houses battery, processor, Bluetooth module; leg units house motors, sensors, controllers. Input: user postural changes (leaning) detected by sensors; operation mimics Segway-style tilt control. Output: motorized leg movement; LED/vibratory feedback for user/therapist. Used in rehabilitation or personal settings; operated by patient with therapist/companion supervision. Wireless mobile app allows real-time adjustment of gait parameters (speed, step length). Failsafe: power failure locks knees, frees hips. Benefits: enables ambulation, sit-to-stand transitions, improved mobility on varied terrain.

Clinical Evidence

Prospective clinical study (n=40) evaluated safety and effectiveness for SCI patients. Primary endpoints: ability to stand/walk and walking speed. Results: 39/40 subjects completed TUG test with minimal assistance; mean walking speed 0.38 ± 0.08 m/s on indoor surfaces; 38/40 subjects completed 600m walk. Adverse events were minor (bruising, abrasion) related to fit/padding; no unanticipated adverse events. Study supports safety/effectiveness for T4-L5 SCI population.

Technological Characteristics

Modular powered exoskeleton; 5 snap-together components. Materials: structural plastics. Sensing: embedded sensors for posture/tilt. Energy: 33.3V rechargeable Li-ion battery (159Wh). Connectivity: Bluetooth for mobile app interface. Software: microprocessor-based control. Standards: ANSI/AAMI ES60601-1 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for adults >18 years with spinal cord injury (SCI) at levels T4 to L5 to perform ambulatory functions. T4-T6 SCI patients are limited to rehabilitation institutional use; T7-L5 SCI patients may use in personal settings. Requires supervision by a specially trained companion. 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™ (DEN130034/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

February 26, 2016

Parker Hannifin Corporation % Richard Vincins Vice President QA/RA Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K152416

Trade/Device Name: Indego Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: January 27, 2016 Received: January 28, 2016

Dear Mr. Vincins:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

for Carlos L. Peña, PhD, MS 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) K152416

Device Name Indego®

#### Indications for Use (Describe)

The Indego® orthotically fits to the lower limbs and the trunk; the device 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 perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# Indego®

# K152416

#### 1. Submission Sponsor

Parker Hannifin Corporation

Human Motion and Control

1390 E. Highland Road

Macedonia

Ohio, 44056

USA

Phone number: 216.896.2044

Contact: Achilleas DOROTHEOU

Title: VPBD/Head, Human Motion and Control

#### 2. Submission Correspondent

Emergo

816 Congress Avenue, Suite 1400

Austin, TX 78701

Office Phone: [phone]

Fax: [phone]

Contact: Richard A. VINCINS, Vice President, QA/RA

Email: [e-mail]

#### 3. Date Prepared

26 February 2016

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#### 4. Device Identification

| Trade/Proprietary Name: | Indego® |
|-------------------------|---------------------|
| Common/Usual Name: | Powered Exoskeletor |
| Classification Name: | Powered Exoskeletor |
| Regulation Number: | 890.3480 |
| Product Code: | PHL |
| Device Class: | Class II |
| Classification Panel: | Neurology |

#### 5. Legally Marketed Predicate Device

DEN130034/K131798, ReWalk™, Argo Medical Technologies, Inc.

#### 6. Device Description

Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections) weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth module, while each upper leg component houses two motors as well as embedded sensors and controllers.

On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to battery technology (smaller size), motors (smaller and more powerful), and micro controllers. Visual cues from LED lights on the hip unit and vibratory feedback inform both the therapist and patient of the status and mode of operation.

The Indego controls are self-contained, with crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. Through the use of a Bluetooth connection, the Indego device's mode of operational parameters such as gait speed and step length/height, will be able to be changed or modified in real time. The device can be utilized in multiple indoor and outdoor locations within a rehabilitation setting or personal setting.

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#### 7. Indication for Use Statement

The Indego® orthotically fits to the lower limbs and the trunk; the device 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 Indego is not intended for sports or stair climbing.

#### 8. Substantial Equivalence Discussion

The following table compares the Indego to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

| Manufacturer | Parker Hannifin | Argo Medical | Significant Differences |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Corporation | Technologies, Inc. | |
| Trade Name | Indego® | ReWalk™ | |
| 510(k) Number | K152416 | DEN130034/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 Indego® orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T7 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is<br>also intended to enable<br>individuals with spinal cord<br>injury at levels T4 to T6 to<br>perform ambulatory<br>functions in rehabilitation | The Argo ReWalk™<br>orthotically fits to the<br>lower limbs and part of the<br>upper body and is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T7 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is<br>also intended to enable<br>individuals with spinal cord<br>injury at levels T4 to T6 to<br>perform ambulatory | Same |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego® | ReWalkTM | |
| | institutions in accordance<br>with the user assessment<br>and training certification<br>program. The Indego is<br>not intended for sports or<br>stair climbing. | functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. The Indego is<br>not intended for sports or<br>stair climbing. | |
| Body Coverage | Worn over legs and<br>around hips and lower<br>torso | Worn over legs and<br>upper body with<br>backpack | Similar; the<br>components are worn<br>around the legs and<br>torso with the control<br>unit of Indego<br>integrated into the hip<br>segment whereas the<br>ReWalk has a separate<br>backpack control unit.<br>No additional safety<br>or efficacy concern as<br>the component<br>configuration is similar<br>for the legs, hip, and<br>torso of the patient. |
| Size of<br>Components | Modular Small,<br>Medium, and Large<br>upper leg, lower leg,<br>and hip components;<br>control unit integrated<br>in hip unit | Adjustable upper leg,<br>lower leg, and multiple<br>size pelvic bands; with a<br>backpack control unit | Similar; both units<br>have an upper leg,<br>lower leg, and hip<br>component with<br>ReWalk having an<br>additional backpack<br>unit. No additional<br>safety or efficacy<br>concerns as the<br>components cover the<br>same areas of the<br>patient including the<br>legs, hip, and torso. |
| Mobility Aid | Crutches or walkers | Crutches | Similar; both devices<br>utilize crutches as a<br>stability/mobility aid. |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego® | ReWalk™ | No additional safety<br>or efficacy concerns<br>are presented by<br>providing the added<br>mobility aid option for<br>the Indego patients to<br>utilize. |
| 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<br>Inclination | 5 degrees | 5 degrees | Same |
| Type of Surface | Smooth, grass, cement,<br>carpet, transitions,<br>thresholds | Smooth, grass, cement,<br>carpet | Similar; Indego<br>provides greater<br>ground clearance<br>which is user-<br>selectable. No<br>additional safety or<br>efficacy concerns as<br>clinical data supports<br>ambulation over a<br>wide range of<br>surfaces. |
| Patient population | Adults over age of 18<br>with Spinal Cord Injury<br>(SCI) from T4 to L5 | Adults over age of 18<br>with Spinal Cord Injury<br>(SCI) from T4 to L5 | Same |
| Height of Patient | 61" to 75" (1.55 m to<br>1.91 m) | 63" to 75" (1.60 m to<br>1.90 m) | Similar; the Indego<br>can accommodate a<br>shorter height with a<br>difference of two<br>inches (5 cm) and<br>does not present any<br>additional safety or<br>efficacy concern. |
| Weight of Patient | Up to 250 lbs (113 kg) | Up to 220 lbs (100 kg) | Similar; the Indego<br>can accommodate a |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego® | ReWalk™ | heavier weight; this<br>does not add any<br>safety or efficacy<br>concerns as the<br>verification and<br>validation testing<br>supports the<br>requirements. |
| Control Method | Uses postural cues to<br>trigger all transitions | Remote control worn on<br>the wrist to change<br>modes; postural cues<br>for stepping | Similar; the<br>movement activation<br>is preceded by the<br>user setting the mode<br>on the control units.<br>No additional safety<br>or efficacy concerns<br>because the postural<br>cues are triggers for<br>the movement<br>activation of the<br>device. |
| Range of Motion | Hip: 110° flexion to 30°<br>extension<br>Knees: 110° flexion to<br>10° extension | Hip: 104° flexion to 34°<br>extension<br>Knees: 112° flexion to 2°<br>extension | Similar; there is a<br>larger range of motion<br>for the Indego device<br>to allow easier sit-to-<br>stand transitions. 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. |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego® | ReWalk™ | |
| Weight | 26 lbs. (12 kg) | 66 lbs. (30 kg) with 5 lbs.<br>(2.3 kg) backpack | Different; Indego is<br>less weight of the<br>predicate device; the<br>lessened weight of the<br>device does not add<br>any concern for safety<br>or efficacy as can be<br>managed by an<br>individual. |
| Rechargeable<br>Battery | Rechargeable lithium<br>ion. 33.3V, 36A peak<br>current, 12A continuous<br>current. 159Wh fully<br>charged; 1.5 hours of<br>continuous walking per<br>charge | Rechargeable lithium<br>ion primary with lithium<br>polymer 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<br>Time | Maximum of 4 hours | Minimum of 4 hours | Similar; the predicate<br>takes a minimum of 4<br>hours and a maximum<br>of 7 hours to be<br>charged. No<br>additional safety or<br>efficacy concern as<br>similar charging time. |
| Expected Useable<br>Life | 5 years | 5 years | Same |
| Training Program | Yes | Yes | Same |
| Certification<br>Program | Yes | Yes | Same |
| User Feedback | Provides vibratory<br>feedback and LED<br>indicators on top of hip | Provides vibratory<br>feedback from backpack<br>and LED indicators on | Similar; both devices<br>provide vibratory<br>feedback and the LED |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego®<br>unit, visible to the<br>wearer | ReWalk™<br>user's wrist controller | indicators to<br>communicate<br>information to the<br>user and do not<br>increase any safety or<br>efficacy concerns. |
| Fall Detection and<br>Mitigation | Detects forward,<br>backward, and sideways<br>falling as it is happening;<br>the device makes<br>adjustments during the<br>course of the fall to<br>position the user for<br>minimal risk of injury | None | Different; there are no<br>additional safety<br>concerns or efficacy as<br>the fall detection<br>methods will help<br>reduce the risk of<br>injury to the user. |
| Failsafe Feature | In event of power failure<br>– knees become locked<br>and hips free (similar to<br>typical passive leg<br>braces) | In the event of a power<br>failure the ReWalk<br>collapses slowly<br>whether user is in safe<br>condition for sitting or<br>not | Similar; the Indego<br>user is allowed to<br>remain standing in the<br>event of a<br>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 device. |
| Operating<br>Temperature | 32°F to 88°F (0°C to<br>31°C) | -13°F to 105°F (-25°C to<br>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<br>Humidity | 30% to 75% RH | Not available | Not applicable |
| Electrical Safety<br>Testing | Passed ANSI/AAMI<br>ES60601-<br>1:2005/(R)2012 | Passed IEC 60601-<br>1:2005 | Similar; the Indego<br>passed the currently<br>recognized electrical<br>safety standard. |
| Manufacturer | Parker Hannifin<br>Corporation | Argo Medical<br>Technologies, Inc. | Significant Differences |
| Trade Name | Indego® | ReWalk™ | |
| Electromagnetic<br>Compatibility<br>Testing | Passed IEC 60601-1-<br>2:2007 | Passed IEC 60601-1-2:<br>2007 | Same |

#### Table 1 - Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Indego device and in showing substantial equivalence to the predicate device of this 510(k) submission, Parker Hannifin completed a number of tests. The Indego device meets all requirements for design characteristics, non-clinical performance testing, EMC/EMI testing, and electrical safety testing to confirm that the output meets the design inputs and specifications for the device.

The Indego device passed all testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- . Maximum Torque Testing: testing to verify the maximum continuous and peak torques that are applied at the knees and hips measured in Nm against defined specifications: PASS
- . Cleaning Chemical Compatibility Testing to verify the integrity of the structural plastics with no significant degradation over five (5) year time period through routine cleaning of the device: PASS
- Component Life Cycle Testing: verification that the device meets the requirements for the major mechanical subsystems to perform safely during the expected use between routine servicing in simulated normal use: PASS
- . Durability Testing: performance testing designed to verify the device meets the factor of safety designated by the ANSI/AAMI ES60601-1 requirements for any mechanical hazards that require the support system maintaining structural integrity and does not decrease over simulated lifetime of use of the device: PASS
- Battery Life Cycle Testing: testing performed for the batteries being cycled through normal use including measuring the full charge amount, capacity of battery, and cycle life over defined periods according to the specification for the battery: PASS
- Storage and Transport Testing: completed testing to support that the device is protected and not damaged during normal, routine shipping according to ISTA standards for drop, compression, and vibration: PASS

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- Software verification and validation testing per FDA Guidance and IEC 62304: conformance of . software development life cycle for the Indego Software System and compliance to the requirements of the FDA guidance document for software contained in a medical device.
- Electrical safety testing per ANSI/AAMI ES60601-1: PASS
- . Electromagnetic compatibility testing per IEC 60601-1-2: PASS

The Indego passed all testing stated above as shown by the acceptable results obtained.

#### 10. Clinical Performance Data

A clinical study was performed with the investigational product, Indego, for assessing the mobility of persons with Spinal Cord Injury (SCI) while using the device. The study was conducted to evaluate the Indego device for safety and effectiveness in allowing persons with SCI who are non-ambulatory to poorly ambulatory to stand up and walk under a variety of conditions. The study was p…