The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

Device Description

The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc.

The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position.

The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.

The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°.

The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.

The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.

Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.

AI/ML Overview

The Modula Power Standing System (MPSS) aims to add standing (and other features) to a power wheelchair. The relevant information from the provided text has been extracted for your request. It should be noted that this is a 510(k) summary, and as such, detailed study information like sample sizes for test sets, the number and qualifications of experts, adjudication methods, and explicit effect sizes for human improvement with AI assistance are typically not part of such submissions, particularly for mechanical devices without AI components.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria (Performance Data) and Reported Device Performance

The acceptance criteria for the Modular Power Standing System (MPSS) are demonstrated by adherence to various ISO standards and by exhibiting similar technological characteristics to the predicate device (Levo C3) and a reference device (Motion Concepts Modular Power Positioning System). The 'Reported Device Performance' columns below reflect the characteristics of the Subject Device (MPSS) as provided in the comparison table.

Acceptance Criteria Category	Specific Acceptance Criterion/Standard	Reported Device Performance (Subject Device - MPSS)	Comparison to Predicate/Reference
Biocompatibility Testing	ISO 10993 Part 5: Testing for in vitro cytotoxicity	Cytotoxicity testing performed	All body contact materials tested (Meshtex fabric, Startex fabric, Spacetex 4000U™ fabric, O-Vinyl fabric, Style 6499 Polyester fabric, Self-Skinning Skin PU Foam).
	ISO 10993 Part 10: Tests for irritation and skin sensitization	Dermal Sensitization testing and/or Primary Skin Irritation testing performed	All body contact materials tested.
Software Verification and Validation	FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Software verification and validation conducted; documentation provided.	The software for this device is considered to have a "Moderate level of Concern."
Electrical Safety & EMC	ISO 7176-21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters.	Complies with ISO 7176-21.	Equivalent to predicate (A) and reference (B) devices.
Mechanical Testing	Relevant ISO 7176 standards for functional verification and device performance.	Testing established correct functionality.	Equivalent to predicate (A) and reference (B) devices for various mechanical aspects.
Weight Capacity	(Implicitly, comparable to predicate/reference withstanding max weight)	250 lbs	Equivalent to reference device (B) with elevate. (Predicate device (A) has 310 lbs, reference (B) has 300 lbs (250lbs with elevate)).
Performance - Tilt	(Implicitly, functional range comparable to predicate/reference)	45°	Functionally equivalent to predicate (A) (35°) and reference (B) (50°).
Performance - Recline	(Implicitly, functional range comparable to predicate/reference)	178°	Functionally equivalent to predicate (A) (info not available) and reference (B) (168°). Note that slight increase in recline compared to (B) is required for effective stand option.
Performance - Elevation	(Implicitly, functional range comparable to predicate/reference)	6.5"	Less than reference (B) which is 12". Offset by stand feature offering alternatives.
Other Mechanical Safety Features	Ensuring stability, drive lock-out, speed reduction, front caster lock to prevent tipping.	Wheelchair remains stable when fully tilted, reclined, elevated, standing. Speed is reduced, drive lock-out, tilt limit available, front caster lock.	Includes safety features equivalent to both predicate (A) and reference (B).
Where Used	Indoor and outdoor use.	Private residences, chronic-care facilities, indoors, outdoors.	Equivalent to predicate (A) and reference (B).
Power Stand-up Feature	Chest support, knee support.	Chest support and knee support standard.	Equivalent to predicate (A).
Motor Type/Voltage/Current/Power	(Implicitly, standard specifications)	Linear actuator, Gear reduction screw type; 24VDC; 4 Amps; 96W	Identical to reference (B). (Predicate (A) info not available)
Standards Met (Detailed list of ISO standards provided)	ISO 7176-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -13, -14, -15, -16, -21, -22, -30; EN 1021-1/-2; California Technical Bulletin 117-2013	Compliance confirmed for listed ISO standards (FDA Recognition Number provided). Compliance for EN 1021-1/-2 and California Technical Bulletin 117-2013 implicitly met.	Equivalent to predicate (A) and reference (B) in meeting relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of subject count for clinical testing. Instead, the performance data refers to various engineering and materials testing (biocompatibility, software, electrical, mechanical). For mechanical and electrical tests, it's typically performed on a limited number of device units rather than a "sample size" of users.
Data Provenance: The testing appears to be internal verification and validation testing performed by Motion Concepts. There is no mention of country of origin for data or whether it was retrospective or prospective in the context of user studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described is primarily engineering-based, not clinical trials requiring human expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the testing is not based on expert review or adjudication of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." The device is a mechanical system, not an AI or imaging device that would typically undergo such a study.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a mechanical device and does not involve AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a mechanical device; there is no "algorithm only" performance study in the context of AI or diagnostic interpretation. The device's performance is its direct mechanical functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized international technical standards (ISO). For example, static stability (ISO 7176-1) is a directly measurable property against a standard, not subject to expert consensus or pathology. Biocompatibility is verified against ISO 10993 standards using laboratory tests.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical product; there is no "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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August 13, 2019

Motion Concepts Dona Bhamra Senior Quality and Regulatory Affairs Manager 84 Citation Drive, Unit #1 Concord, L4K 3C1 Canada

Re: K191376

Trade/Device Name: Modular Power Standing System Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: May 17, 2019 Received: May 23, 2019

Dear Dona Bhamra:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Vivek J. Pinto. PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191376

Device Name Modular Power Standing System (MPSS)

Indications for Use (Describe)

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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

l. SUBMITTER

II.

III.

FDA Establishment Registration Number:	9615350
Address:	Motion Concepts84 Citation Drive, Unit 1Concord, Ontario, L4K 3C1
Phone:	905-695-0134
Fax:	905-695-0138
Contact person:	Dona Bhamra
Date Summary Prepared:	1-Aug-2019

DEVICE
Device Proprietary Name:	Modular Power Standing System (MPSS)
Common Name:	Standup Wheelchair
Classification Regulation:	21 CFR, 890.3900
Product Code:	IPL
Classification of Device:	Class II

PREDICATE DEVICE
Predicate Device:	Levo C3 Power Wheelchair
	K083017
	Product Code IPL
	21 CFR 890.3900
Reference Device:	Motion Concepts Modular Power Positioning System
	K150574
	Product Code ITI
	21 CFR 890.3860

IV. DEVICE DESCRIPTION

The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.

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510(k) Summary Modular Power Standing System

The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.

The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.

V. INDICATIONS FOR USE

The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the provide safe and reliable powered repositioning on the equipment onto which they are installed.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The new Modular Power Standing System was designed to add the standing function option to the existing Motion Concepts Modular Power Positioning System functions of tilt, recline, and elevate. This new standing feature functions similarly to the Levo C3 K083017, which will therefore serve as the Predicate device. In order to further demonstrate safety and effectiveness the Modular Power Position System K150574 will also be used as a reference device.

Predicate device: Levo C3 (K083017)

Both the subject device Modular Power Standing System (MPSS) and the predicate device Levo C3 Power Wheelchair are systems which provide a stand-up feature, allowing users to reposition themselves from seating to standing and vice versa. Both systems include both a knee support to help stabilize the user in the standing position.

The two systems are equivalent with respect to the following:

ー indications for use
ー target population

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510(k) Summary Modular Power Standing System

safety features l
general design
use of materials l
standards met

The seat size (width/depth/back height) differs in that the MPSS does not offer the smaller seat sizes offered on the predicate device. This difference does not affect the effectiveness of the MPSS over the range offered.

Reference Device Motion Concepts Modular Power Position System (K150574)

Both the subject device Modular Power Standing System (MPSS) and reference device Modular Positioning System are seating systems that provide three basic functions: power recline including shear reduction and power elevate.

The two systems are equivalent with respect to the following:

safety features l
electrical safety
general design
use of materials
| energy used
motor type used
standards met ।

The seat size (width/depth/back height) differs in that the MPSS does not offer the larger seat sizes offered on the referenced device. This difference does not affect the effectiveness of the MPSS over the range offered.

The elevate range on the referenced device is less than that offered on the MPSS, however the effectiveness is maintained as the standing function improves the reach and accessibility available to the user.

VII. PERFORMANCE DATA

।

The following performance data has been provided in support of the substantial equivalence determination.

Biocompatibility Testing

Bio-Compatibility testing requirements were evaluated for all potential body (skin) contacting O materials. Cytotoxicity testing was performed per 'ISO 10993 Part 5: Testing for in vitro cytotoxicity', and Dermal Sensitization testing and/or Primary Skin Irritation testing was performed per 'ISO 10993 Par10: Tests for irritation and skin sensitization'. Testing was conducted on all body contact materials on the MPSS, including: Meshtex fabric, Startex fabric, Spacetex 4000U™ fabric, O-Vinyl fabric, Style 6499 Polyester fabric, Self-Skinning Skin PU Foam (Bolasto F380 (RN7548)).

l Software Verification and Validation Testing

o Software verification and validation testing have been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to have a "Moderate level of Concern" because "prior to mitigation of hazards, a failure of the Software Device could result in Minor Injury, either to a patient or to a user of the device."
-Electrical Safety and electromagnetic compatibility (EMC)

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510(k) Summary

Modular Power Standing System

o Electromagnetic Compatibility testing has been conducted on the Modular Power Standing System. The system complies with ISO 7176-21, Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters.

-Mechanical and acoustic testing

Mechanical testing of the Modular Power Standing System was carried out to cover functional o verification and device performance. Testing established correct functionality according to the relevant ISO 7176 standards. No acoustic testing was required to demonstrate device safety and effectiveness of the subject device.
। Animal Study
o Animal performance testing was not required to demonstrate the safety and effectiveness of the subject device.
-Clinical Studies
- Clinical testing was not required to demonstrate the safety and effectiveness of the subject device. o

The following table provides a comparison of technological characteristics with the predicate device (Levo X3) and the reference device (Modular Power Positioning System) to demonstrate substantial equivalence.

	Subject Device	Predicate (A)	Reference device (B)
	Motion Concepts ModularPower Standing System	Levo C3	Motion Concepts ModularPower Positioning System	Comparison
510k number	N/A	K083017	K150574	N/A
Product Code	IPL 890.3900	IPL 890.3900	ITI 890.3860	The subject deviceis identical to (A)
Indications forUse	The Modular Power StandingSystem is appropriate for use byindividuals who drive a powerwheelchair and cannot stand upon their own. The ModularPower Standing System allowssuch users to change positionincluding from seating tostanding, standing to seating, orany position in between. Thedevice is appropriate for indoorand outdoor use. MotionConcepts makes no claims as tothe therapeutic effectiveness ofthe products. Our only claimsrelate to the ability of theproducts to provide safe andreliable powered repositioningon the equipment onto whichthey are installed.	The LEVO C3 powerwheelchair with optionalseating and standing positionfunction may be of interestfor any individuals whoneeds a power wheelchairand cannot stand up on theirown such as people withspinal cord injury, spinabifida, cerebral palsy,multiple sclerosis, musculardystrophy, polio,rheumatism, etc	N/A	The subject deviceis equivalent to (A).
	Subject DeviceMotion Concepts ModularPower Standing System	Predicate (A)Levo C3	Reference device (B)Motion Concepts ModularPower Positioning System
Picture (instanding mode)			N/A	The subject deviceis equivalent to (A)for standingfunction.
Picture (intilt/recline/elevate mode)				The subject deviceis equivalent to (B)for tilt, recline, andelevate functions.
TargetPopulation	Paraplegics or quadriplegicsPeople with spinal cordinjury, spina bifida, cerebralpalsy, multiple sclerosis,muscular dystrophy, polio,rheumatism, and otherdiseases and conditionswhich cause the individualto require a powerwheelchair and not be ableto shift his/her weight	The LEVO C3 powerwheelchair with optionalseating and standing positionfunction may be of interestfor any individuals whoneeds a power wheelchairand cannot stand up on theirown such as people withspinal cord injury, spinabifida, cerebral palsy,multiple sclerosis, musculardystrophy, polio,rheumatism, etc..	Quadriplegicspersons with ALS, MS,spinal muscularatrophy, and any otherdisability which causesthe individual torequire a powerwheelchair and not beable shift his/herweight	The subject deviceis equivalent to (A).
Design	Link based mechanismspowered by electro-mechanicallinear actuators	Link based mechanismspowered by electro-mechanical linear actuators	Link based mechanismspowered by electro-mechanical linear actuators	The subject deviceis equivalent to (A)and (B).
Materials	steel tube and plate, aluminum,powder-coated	steel tube and plate,aluminum, powder-coated	steel tube and plate,aluminum, powder-coated	The subject deviceis equivalent to (A)and (B).
Weight Capacity	250 lbs	310 lbs	300 lbs (250lbs withelevate)	The subject deviceis equivalent to (B)with elevate.
Performance -Tilt	45°	35°	50°	The subject isfunctionallyequivalent to (A)and (B)
Performance -Recline	178°	Info Not available	168°	The subject deviceis functionallyequivalent to (A)and (B). It is notedthat the slight
	Subject DeviceMotion Concepts ModularPower Standing System	Predicate (A)Levo C3	Reference device (B)Motion Concepts ModularPower Positioning System	Comparison
Performance –Elevation	6.5"	N/A	12"	increase inmaximum amountof recline comparedto (B) is required toprovide an effectivestand optionThe subject devicehas less elevationthan (B), This isoffset by the standfeature which offersalternatives forcomfort, positioningand versatility.
Seat width range	16 to 21 inches	12.5 to 20.5 inches	15 to 24 inches	The subject devicehas smaller widthrange than (A) or (B)
Seat depth range	16 to 20 inches	13.75 to 25 inches	15 to 22 inches	The subject devicehas smaller depthrange than (A) or (B)
Back heightrange	20 to 28 inches	12 to 21.5"	18 to 30 inches	The subject devicehas smaller backheight range than(B)
MechanicalSafety	- wheelchair remains stablewhen fully tilted, reclinedseat, elevated, standingspeed is reduced whenpatient is positionedbeyond pre-set limits.- drive lock-out prevents userfrom driving power chairwhile tilted beyond a pre-set limits- tilt limit is available- Front caster lock to reducerisk of tipping forward whilein stand-up position	- The speed is reduced tohalf speed as soon asthe patient is not in thesitting position	- wheelchair remainsstable with fullyelevated, tilted, andreclined seat - center-of-gravity shift furtherenhances stability- drive lock-out preventsuser from drivingpower chair while tiltedbeyond a pre-set limitspeed is reduced whenpatient is positionedbeyond pre-set limits.- tilt limit is available	The subject deviceincludes safetyfeatures equivalentto those listed forboth (A) and (B)
Where Used	- private residences- chronic-care facilities- indoors, outdoors	The product provides highindoor and outdoor mobilityon surfaces like tar, grassand gravel	- private residenceschronic-care facilitiesindoors, outdoors-	The subject deviceis equivalent to (A)and (B).
Electrical Safety	- electrical components are24 volts maximumcurrent limit built into relaybox	Info Not available	- electrical componentsare 24 volts maximumcurrent limit built intorelay box	Identical to (B)
Energy Used	24 VDC Wheelchair Batteries	24 VDC Wheelchair Batteries	24 VDC WheelchairBatteries	Identical to (A) and(B).
	Subject Device	Predicate (A)	Reference device (B)
	Motion Concepts Modular	Levo C3	Motion Concepts Modular	Comparison
	Power Standing System		Power Positioning System
Power stand-upfeature	Chest support and knee supportstandard	Chest support and kneesupport standard	Not Applicable	The subject deviceis equivalent to (A)
Motor Type	Linear actuator,Gear reduction screw type	Info Not available	Linear actuator,Gear reduction screw type	Identical to (B)
Motor Voltage	24VDC	Info Not available	24VDC	Identical to (B)
Motor MaximumCurrent	4 Amps	Info Not available	4 Amps	Identical to (B)
Power	96W	Info Not available	96W	Identical to (B)
Standards Met	ISO 7176 see details below	ISO 7176ANSI/RESNA	RESNA WC-1:2009RESNA WC-2:2009	The subject deviceis equivalent to (A)and (B).

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510(k) Summary
Modular Power Standing System Motion opts

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Motion opts

510(k) Summary

Modular Power Standing System

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Motion

510(k) Summary

Modular Power Standing System

Standards Met

Standard	Description	FDA RecognitionNumber
ISO 7176-1:2014	Wheelchairs - Part 1: Determination of static stability	16-195
ISO 7176-2:2017	Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs	16-202
ISO 7176-3:2012	Wheelchairs - Part 3: Determination of effectiveness of brakes	16-192
ISO 7176-4:2008	Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range	16-162
ISO 7176-5:2008	Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space	16-163
ISO 7176-6:2018	Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs	16-204
ISO 7176-7:1998	Wheelchairs - Part 7: Measurements of seating and wheel dimensions	16-196
ISO 7176-8:2014	Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths	16-197
ISO 7176-9:2009	Wheelchairs - Part 9: Climatic tests for electric wheelchairs	16-167
ISO 7176-10:2008	Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs	16-164
ISO 7176-11:2012	Wheelchairs - Part 11: Test dummies	16-190
ISO 7176-13:1989	Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces	16-25
ISO 7176-14:2008	Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods	16-165

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Page 8 of 8

MotionConcepts

510(k) Summary Modular Power Standing System

Standard	Description	FDA RecognitionNumber
ISO 7176-15:1996	Wheelchairs – Part 15: Requirements for information disclosure, documentation andlabelling	16-27
ISO 7176-16:2012	Wheelchairs – Part 16: Resistance to ignition of postural support devices	16-191
ISO 7176-21:2009	Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibilityof electrically powered wheelchairs and scooters, and battery chargers	16-166
ISO 7176-22:2014	Wheelchairs – Part 22: Set-up procedures	16-198
ISO 7176-30:2018	Wheelchairs – Part 30: Wheelchairs for changing occupant posture – Test methods andrequirements	N/A
ISO 10993-5:2009	Part 5: Biological Evaluation of Medical Devices – Tests For In Vitro Cytotoxicity	2-245
ISO 10993-10:2010	Part 10: Biological Evaluation of Medical Devices – Tests for irritation and skin sensitization	2-174
EN 1021-1/-2:2014	Testing of Ignitability For Upholstered Furniture	N/A
California TechnicalBulletin 117-2013	Requirements, Test Procedure and Apparatus For Testing The Smolder Resistance OfMaterials Used In Upholstered Furniture	N/A

Conclusion

The Modular Power Standing System has similar technological characteristics as the predicate device Levo C3 Power Wheelchair. The non-clinical testing and the comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety and effectiveness. Thus, the Modular Power Standing System has demonstrated that it is as safe, as effective and performs as well as the predicate device.

Therefore, it can be concluded that Modular Power Standing System is substantially equivalent to:

Predicate Device:

Levo C3 Power Wheelchair K083017 Product Code IPL 21 CFR 890.3900

Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).