Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical linkages, linear actuators, and basic electrical controls (switches, joystick). There is no mention of AI, ML, or any form of intelligent processing or learning. The safety features described are based on pre-set limits and mechanical locks, not adaptive or learning algorithms.

Therapeutic

No. The manufacturer explicitly states, "Motion Concepts makes no claims as to the therapeutic effectiveness of the products." The device focuses on repositioning and improving accessibility for power wheelchair users.

Diagnostic

No

The device is described as a seating system for power wheelchairs that allows users to change position (e.g., sitting to standing) and does not involve any diagnostic functions. The "Intended Use" section explicitly states that Motion Concepts makes no claims as to therapeutic effectiveness, only to "safe and reliable powered repositioning."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical system with mechanical components (linkages, linear actuators, knee support, backrest, seat pan), electrical components (actuators, seat control box), and materials (steel, aluminum). It is a hardware device with integrated software for control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide powered repositioning (standing, tilting, reclining, elevating) for individuals who use power wheelchairs and cannot stand on their own. This is a physical function, not a diagnostic one.
Device Description: The device is a seating system added to a power wheelchair. Its components and functions are related to physical movement and positioning.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
Performance Studies: The performance studies focus on safety, mechanical function, electrical compatibility, and biocompatibility – all relevant to a medical device for physical support and mobility, but not to an IVD.
Predicate and Reference Devices: The predicate and reference devices are power wheelchairs and power positioning systems, which are not IVDs.

In summary, the Modular Power Standing System is a medical device designed to assist with mobility and positioning, not to perform in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, 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.

Product codes

IPL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The device is appropriate for indoor and outdoor use.

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)

Biocompatibility Testing: Bio-Compatibility testing requirements were evaluated for all potential body (skin) contacting 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)).

Software Verification and Validation Testing: 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): 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: 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.

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

Not Found

Predicate Device(s)

K083017

Reference Device(s)

K150574

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out in a clear, sans-serif font.

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

1

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

2

Indications for Use

510(k) Number (if known) K191376

Device Name Modular Power Standing System (MPSS)

Indications for Use (Describe)

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.

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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3

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 Concepts
84 Citation Drive, Unit 1
Concord, 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 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°.

4

510(k) Summary Modular Power Standing System

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.

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

5

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)

6

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 Modular
Power Standing System	Levo C3	Motion Concepts Modular
Power Positioning System	Comparison
510k number	N/A	K083017	K150574	N/A
Product Code	IPL 890.3900	IPL 890.3900	ITI 890.3860	The subject device
is identical to (A)
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, 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.	The LEVO C3 power
wheelchair with optional
seating and standing position
function may be of interest
for any individuals who
needs a power wheelchair
and cannot stand up on their
own such as people with
spinal cord injury, spina
bifida, cerebral palsy,
multiple sclerosis, muscular
dystrophy, polio,
rheumatism, etc	N/A	The subject device
is equivalent to (A).
	Subject Device
Motion Concepts Modular
Power Standing System	Predicate (A)
Levo C3	Reference device (B)
Motion Concepts Modular
Power Positioning System
Picture (in
standing mode)			N/A	The subject device
is equivalent to (A)
for standing
function.
Picture (in
tilt/recline/eleva
te mode)				The subject device
is equivalent to (B)
for tilt, recline, and
elevate functions.
Target
Population	Paraplegics or quadriplegics
People with spinal cord
injury, spina bifida, cerebral
palsy, multiple sclerosis,
muscular dystrophy, polio,
rheumatism, and other
diseases and conditions
which cause the individual
to require a power
wheelchair and not be able
to shift his/her weight	The LEVO C3 power
wheelchair with optional
seating and standing position
function may be of interest
for any individuals who
needs a power wheelchair
and cannot stand up on their
own such as people with
spinal cord injury, spina
bifida, cerebral palsy,
multiple sclerosis, muscular
dystrophy, polio,
rheumatism, etc..	Quadriplegics
persons with ALS, MS,
spinal muscular
atrophy, and any other
disability which causes
the individual to
require a power
wheelchair and not be
able shift his/her
weight	The subject device
is equivalent to (A).
Design	Link based mechanisms
powered by electro-mechanical
linear actuators	Link based mechanisms
powered by electro-
mechanical linear actuators	Link based mechanisms
powered by electro-
mechanical linear actuators	The subject device
is 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 device
is equivalent to (A)
and (B).
Weight Capacity	250 lbs	310 lbs	300 lbs (250lbs with
elevate)	The subject device
is equivalent to (B)
with elevate.
Performance -
Tilt	45°	35°	50°	The subject is
functionally
equivalent to (A)
and (B)
Performance -
Recline	178°	Info Not available	168°	The subject device
is functionally
equivalent to (A)
and (B). It is noted
that the slight
	Subject Device
Motion Concepts Modular
Power Standing System	Predicate (A)
Levo C3	Reference device (B)
Motion Concepts Modular
Power Positioning System	Comparison
Performance –
Elevation	6.5"	N/A	12"	increase in
maximum amount
of recline compared
to (B) is required to
provide an effective
stand option
The subject device
has less elevation
than (B), This is
offset by the stand
feature which offers
alternatives for
comfort, positioning
and versatility.
Seat width range	16 to 21 inches	12.5 to 20.5 inches	15 to 24 inches	The subject device
has smaller width
range than (A) or (B)
Seat depth range	16 to 20 inches	13.75 to 25 inches	15 to 22 inches	The subject device
has smaller depth
range than (A) or (B)
Back height
range	20 to 28 inches	12 to 21.5"	18 to 30 inches	The subject device
has smaller back
height range than
(B)
Mechanical
Safety	- wheelchair remains stable
when fully tilted, reclined
seat, elevated, standing
speed is reduced when
patient is positioned
beyond pre-set limits.

```
        drive lock-out prevents user
```

from driving power chair
while tilted beyond a pre-
set limits

```
        tilt limit is available
```
```
        Front caster lock to reduce
```

risk of tipping forward while
in stand-up position | - The speed is reduced to
half speed as soon as
the patient is not in the
sitting position | - wheelchair remains
stable with fully
elevated, tilted, and
reclined seat - center-
of-gravity shift further
enhances stability

```
        drive lock-out prevents
```

user from driving
power chair while tilted
beyond a pre-set limit
speed is reduced when
patient is positioned
beyond pre-set limits.

        tilt limit is available | The subject device

includes safety
features equivalent
to those listed for
both (A) and (B) |
| Where Used | - private residences

```
        chronic-care facilities
```

        indoors, outdoors                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | The product provides high

indoor and outdoor mobility
on surfaces like tar, grass
and gravel | - private residences
chronic-care facilities
indoors, outdoors

                                                                                                                                                                                                                                                                                                           | The subject device

7

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510(k) Summary
Modular Power Standing System Motion opts

8

Motion opts

510(k) Summary

Modular Power Standing System

9

Motion

510(k) Summary

Modular Power Standing System

Standards Met

| Standard | Description | FDA Recognition
Number |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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 |

10

Page 8 of 8

MotionConcepts

510(k) Summary Modular Power Standing System

| Standard | Description | FDA Recognition
Number |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| ISO 7176-15:1996 | Wheelchairs – Part 15: Requirements for information disclosure, documentation and
labelling | 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 compatibility
of 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 and
requirements | 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 Technical
Bulletin 117-2013 | Requirements, Test Procedure and Apparatus For Testing The Smolder Resistance Of
Materials 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