Quickie(r) Q700-UP M

K172384 · Sunrise Medical (Us), LLC · IPL · Jan 16, 2018 · Physical Medicine

Device Facts

• Record ID: K172384
• Device Name: Quickie(r) Q700-UP M
• Applicant: Sunrise Medical (Us), LLC
• Product Code: IPL · Physical Medicine
• Decision Date: Jan 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

Device Story

Battery-operated center-wheel-drive power wheelchair; provides mobility and stand-up functionality. Input: user joystick commands. Transformation: PG Drives Technology R-Net controller processes inputs to drive motors, brakes, and actuators. Output: wheelchair movement and seat articulation (stand-up, tilt, recline). Used in homes and care facilities; operated by patient or attendant. Features caster/suspension lock-out system for stability during standing. Benefits: facilitates reaching, eye-level interaction, and comfortable resting positions for users unable to stand.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including static/dynamic stability, brake effectiveness, energy consumption, obstacle climbing, electromagnetic compatibility, and performance testing for stand-up wheelchairs per ISO 7176 and RESNA standards.

Technological Characteristics

Steel/aluminum welded frame, powder-coated; ABS plastic shrouds. Center-wheel-drive; 24V DC power; PG Drives R-Net controller. 14" drive wheels; 6" front/rear casters. 120A controller output. Compliant with ISO 7176 series (stability, brakes, energy, dimensions, strength, climate, obstacle, EMC) and RESNA WC-1:2009 Section 20.

Indications for Use

Indicated for patients with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, and other conditions limiting mobility who require a power wheelchair and cannot stand independently.

Regulatory Classification

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.

Predicate Devices

• Levo C3 Power Wheelchair (K083017)

Reference Devices

• Sunrise Medical Quickie® Pulse 6SC (K142457)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 16, 2018

Sunrise Medical (US) LLC Nancy Gertlar Senior Director, Regulatory Affairs and Quality Assurance 2842 Business Park Ave Fresno. California 93727

Re: K172384

Trade/Device Name: Quickie® Q700-UP M Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: December 8, 2017 Received: December 14, 2017

Dear Nancy Gertlar:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Vivek J. Pinto -S

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) K172384

Device Name Quickie(R) Q700-UP M

Indications for Use (Describe)

The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

| 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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# 510(k) SUMMARY

| Submitted By: | Nancy J Gertlar<br>Sunrise Medical (US) LLC<br>2842 Business Park Ave<br>Fresno, CA 93727<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nancy J Gertlar<br>Senior Director Regulatory Affairs and Quality Assurance<br>[e-mail] |
| Date Summary Prepared: | December 1, 2017 |
| Trade Name: | Quickie® Q700-UP M |
| : Common/<br>Classification Name: | Wheelchair, Standup<br>Standup wheelchair |
| Product Code | IPL<br>21 CFR 380.3900 |
| Primary Predicate Device: | Levo C3 Power Wheelchair<br>K083017<br>Product Code IPL<br>21 CFR 890.3900 |
| Reference Device: | Sunrise Medical Quickie® Pulse 6SC<br>K142457<br>Product Code ITI |

## Description of the Q700-UP M:

This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC: (illustration follows)

- 1. Requires a knee block that was a previous option
- 2. Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature
- 3. Requires a different version of the power center leg-rest to support the patient's weight when standing.

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- 4. Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing
- 5. A caster / suspension lock-out system to stabilize the base when stand-up is actuated.

Image /page/4/Figure/2 description: The image shows the Q700-UP M, which is a wheelchair with new components. The image highlights the caster/suspension lock-out system, which stabilizes the base when the stand-up system is actuated. Other components shown are the knee block, CXSM power seating control module, stand-up actuator module, and a different version of the power center mount legrest designed to support the weight of the user.

The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

### Q700-UP M

The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own. This chair is intended for patients with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, and other diseases and conditions which limit a patient's mobility.

### Indications for Use

The indications for use of the Quickie® Q700-UP M are listed in the table (Table 1) below and compared to the primary predicate device, the Levo C3. The table also demonstrates that the indications for use of the Quickie® Q700-UP M are substantially equivalent to the Levo C3.

| Quickie® Q700-UP M | Levo C3 (Primary Predicate) | Comparison |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------|
| K172384 | K083017 | |
| The Sunrise Medical Quickie®<br>Q700-UP M power wheelchairs<br>are battery operated devices, | The LEVO C3 power<br>wheelchair<br>with optional seating and | Equivalent |

#### Table 1. Primary Predicate Comparison of Indications For Use

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| that are indicated for medical<br>purposes to provide mobility<br>and repositioning of the user,<br>including a stand-up feature. | standing position function may<br>be of interest for any individuals<br>who needs a power wheelchair<br>and cannot stand up on their<br>own such as people with spinal<br>cord injury, spina bifida,<br>cerebral<br>palsy, multiple sclerosis, | |
|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | muscular dystrophy, polio. | |
| | rheumatism, etc.. | |

#### Principles of Operation

Sunrise Medical power wheelchairs use components tvpically found on most wheelchairs, including but not limited to rigid seat frame, backrest, push handles, armrests, cushion, footrests and casters. The wheelchair can be customized with various optional add-ons. Accessories that may be added after-market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders and IV poles. The Sunrise Medical power wheelchairs are center-wheel-drive power wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring.

The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair. A control system (i.e., controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who can drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant controller is fully programmable.

The new feature for this model, the Quickie® Q700-UP M, is the ability for the patient to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues and provide more comfortable resting positions.

The actuator added for this feature articulates the chair (under the joystick's control) and seating to allow the patient position to come to a standing position if desired. The seating, straps, knee brace and leg rests stabilize the patient so they do not slip down and slump during the stand-sit or sit-stand operation.

#### Predicate Comparison of Major Technical Features

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The following tables provides a comparison of the primary predicate device (Levo C3 – Table 2) and the reference device (Quickie Pulse 6SC - Table 3) with the QM700-UP M to demonstrate substantial equivalence.

| Feature | Primary<br>Predicate: Levo<br>C3 Power<br>Wheelchair | Q700-UP M Power<br>Wheelchair | Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K083017 | K172384 | |
| Product Code | IPL 890.3900 | IPL 890.3900 | Identical |
| Device Description | The LEVO C3 with<br>optional<br>seating and<br>standing position<br>function is center<br>wheel driven,<br>battery powered,<br>motor driven<br>power wheelchair<br>and is<br>controlled by the<br>PG Drives<br>Technology's<br>power wheelchair<br>controller "VR2".<br>The joystick is<br>integrated in the<br>controller. The<br>wheelchair is<br>powered by two<br>12V/55Ah or two<br>12V/72Ah<br>batteries with a<br>theoretical<br>driving range of<br>25km (55Ah),<br>35km (72Ah). The<br>LEVO C3<br>power wheelchair is<br>a product<br>which changes<br>people's position<br>in/from seating or/to<br>standing but | Q700-UP M<br>powered<br>wheelchairs:<br>• Are center-wheel-<br>drive power<br>wheelchairs<br>• Perform optimally<br>on firm<br>even surfaces such<br>as<br>concrete, asphalt<br>and indoor<br>flooring<br>• Designed to:<br>- Overcome a<br>maximum<br>obstacle height of<br>2.5" (not in<br>standing mode)<br>- Operate at a<br>maximum incline<br>angle for safe<br>operation of 10°<br>(not in standing<br>mode)<br>- Travel a maximum<br>distance of<br>21 miles on fully<br>charged<br>battery<br>- Work indoors and<br>out at care<br>facilities and private<br>residences | Equivalent |
| | also any position in<br>between.<br>The electrical<br>positioning change<br>is integrated in an<br>electrical<br>center wheel drive<br>power<br>wheelchair that<br>performs high<br>indoor and outdoor<br>mobility in<br>any optional<br>possible position.<br>For security, the<br>speed is<br>reduced to half<br>speed as soon<br>as the patient is not | - The wheelchair is<br>powered by<br>2 12V Group 24 or<br>Group 34<br>batteries<br>- It is controlled by<br>PG Drives<br>Technology's<br>power<br>wheelchair<br>controller "R-Net"<br>and has a slow<br>"Creep Mode"<br>speed when in the | |
| Picture (in standing<br>mode) | Image: Wheelchair in standing mode | Image: Wheelchair in standing mode | Equivalent |
| Seat width | 12.6 - 20.5 inches | 16 – 22" | Equivalent |
| Total width | 24.8 inches | 25" | Equivalent |
| Total length | 41.3 inches | 36" | Functionally<br>Equivalent |
| Seat plate depth | 13.8–24.8 inches | 16 – 22" | Functionally<br>Equivalent |
| Armrest height | 5.9-14.1 inches | 6.3"-12" | Functionally<br>Equivalent |
| Turning circle | 43 inches | 43 inches | Identical |
| Speed | 3.7/ 5 /6.2 mph<br>options | 6 or 8 mph options | Functionally<br>Equivalent |
| Range (with 55 Ahr<br>Batteries) | 15.5 miles | 21 miles | Functionally<br>Equivalent |
| Manageable<br>gradient | 15° (33%) actually<br>28% | 10° (18%) | Functionally<br>Equivalent |
| Max. curb height | 4 inches | 4 inches | Identical |
| Max. chair weight | 407 lbs. | 375 lbs. | Equivalent |
| Max. user weight | 310 lbs. | 265 lbs. | Reduced weight<br>capacity |
| Transport volume<br>max. | 37.8 x 24.8 x 27.1<br>inches | 41 "x 25"x 29" | Functionally<br>Equivalent |

Table 2. Predicate Comparison with the Primary Predicate

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| Controller(s) | PGDT VR-2<br>Controller Std.<br>PGDT R-Net<br>Controller Optional | PGDT R-Net<br>Controller Std. | Equivalent |
|---------------------------|-------------------------------------------------------------------|-----------------------------------------------|------------|
| Joystick Mounting | Standard<br>Swing-away<br>Retractable | Standard<br>Swing-away<br>Retractable | Equivalent |
| Attendant Controls | Optional, for VR-2<br>or R-Net | Optional, for R-Net | Equivalent |
| Batteries | Group 22Sealed<br>lead — 48 AH<br>Group 24Sealed<br>Gel — 73 AH | Group 24 – 73Ahr<br>Group 34 -50 Ahr | Equivalent |
| Power stand-up<br>feature | Requires chest<br>support and<br>knee support<br>options | Chest support and<br>knee<br>support standard | Identical |
| Light kit option: | Front & Rear with<br>Turn Signal | Front & Rear with<br>Turn Signal | Identical |

## Table 3. Comparison with the Reference Device

| Feature | Reference Device:<br>Quickie Pulse 6SC | Q700-UP M Power<br>Wheelchair | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 510(k) Number | K 142457 | K 172384 | |
| Product Code | ITI 890.3860 | IPL 890.3900 | Additional stand-up<br>feature |
| GENERAL | | | |
| User Weight (Max) | 300 lb. | 265 lb. | Equivalent<br>(limited by standup<br>feature) |
| Structural Materials | Steel and<br>aluminum frame<br>structure which is<br>welded and<br>powder coated and<br>utilizes<br>standard foams<br>and covers for<br>the seat. | Steel and aluminum<br>frame<br>structure which is<br>welded and<br>powder coated and<br>utilizes<br>standard foams and<br>covers for<br>the seat. | Identical |
| Biocompatibility | Uses materials<br>common to many<br>Wheelchairs. | Uses materials<br>common to many<br>Wheelchairs. | Identical |
| Maximum speed | 6.0 mph for<br>Quickie® Pulse<br>6SC<br>power wheelchairs | 6.0 mph, with 8.0<br>mph option | Equivalent |
| BASE | | | |
| Overall dimensions<br>(width x length) | 24" x 34" | 25" x 36" | Equivalent |
| Maximum total<br>weight of base | 130 lbs. | 152 lbs. | Equivalent |
| Batteries | 22NF, 52 Ahr<br>sealed lead acid or<br>gel cell<br>batteries | 24V (2x12V) / 73<br>Ah/20h.<br>Maintenance free<br>or<br>24V (2x12V) / 60<br>Ah/20h.<br>Maintenance free | Equivalent |
| Drive wheels | 13" diameter | 14" diameter | Equivalent |
| Caster wheels | 7" front, 6" rear | 6" Front & Rear | Equivalent |
| Motors/gearbox | DC Permanent<br>Magnet motor<br>with gearbox<br>Output speed:<br>163rpm<br>Gear ratio: 26:1<br>Peak power: 910 W<br>@ 90A | 6.0 Motor Package<br>Output Speed: 163<br>rpm<br>Gear Ratio: 26:1<br>Peak Power:1026W<br>@120A<br>8.0 mph Motor<br>Package:<br>Output speed: 220<br>rpm<br>Gear Ratio: 26:1<br>Peak Power:<br>1293W @120A | Equivalent |
| Anti-pitch<br>mechanism for<br>climbing | Additional anti-pitch<br>lock-out. | Additional anti-pitch<br>lock-out. | Equivalent |
| Cosmetic | Product is made<br>from a steel<br>tubular box frame,<br>with cast<br>aluminum front and<br>rear caster<br>arms and shrouded<br>with ABS<br>plastic covers | Product is made<br>from a steel<br>tubular box frame,<br>with cast<br>aluminum front and<br>rear caster<br>arms and shrouded<br>with ABS<br>plastic covers | Equivalent |
| Picture | | | Equivalent |
| | | | |
| Seat options | Standard rehab seat<br>(accommodates after-market seating).<br>Captain's seat.<br>Comes with cushions and<br>upholstery. | SEDEO UP Recline<br>(required by stand-up feature) | Equivalent |
| Minimum seat<br>height | 16.2" | 16.2" | Identical |
| Lift, tilt, recline<br>range | Lift range 0-12"<br>Tilt range 0-50°<br>Recline range 0-<br>172° | Lift range 0-12"<br>Tilt range 0-50°<br>Recline range 0-<br>172° | Identical |
| Lift, tilt, recline<br>capacity | Lift capacity 300<br>lbs.<br>Tilt capacity 300<br>lbs.<br>Recline capacity<br>250 lbs. | Lift capacity 265<br>lbs.<br>Tilt capacity 265<br>lbs.<br>Recline capacity<br>265 lbs. | Equivalent (limited<br>by stand-up<br>feature) |
| Seat dimensions | Width 12-24"<br>Depth 12-22" | Width 16 - 22"<br>Depth 16 - 22" | Equivalent |
| CONTROLLER | | | |
| Controller type | VR2 from PGDT<br>(standard)<br>R-Net from PGDT<br>(optional) | R-Net from PGDT | Equivalent (limited<br>by stand-up<br>feature) |
| Supply voltage | 24 V dc | 24 V dc | Identical |
| Operating voltage | 35 V dc | 35 V dc | Identical |
| Reverse battery<br>voltage | -40 V dc | -40 V dc | Identical |
| PWM frequency | 19.5 kHz ± 1% | 19.5 kHz ± 1% | Identical |
| Brake voltage | Harness with in-line<br>connector | Harness with in-line<br>connector | Identical |
| Brake current | Minimum 100 mA<br>Maximum 1 A | Minimum 100 mA<br>Maximum 1 A | Identical |
| Charging current | 12 A rms max | 12 A rms max | Identical |
| Charger connection | Only Neutrik NC3MX | Only Neutrik NC3MX | Identical |
| Actuator current | Maximum 10 A | Maximum 10 A | Identical |
| Maximum drive current | VR290: 90A<br>R-Net EL 90: 90A | RNet 120A Controller | Equivalent with additional max current output. |
| Moisture resistance | Compliant with ANSI RESNA WC-9 | Compliant with ANSI RESNA WC-9 | Identical |
| Operating temperature | -25°C to 50°C | -25°C to 50°C | Identical |
| Storage temperature | -40°C to 70°C | -40°C to 70°C | Identical |
| Joystick Mount | Fixed mount (standard)<br>Height adjustable (standard)<br>Swing-away (option) | Fixed mount (standard)<br>Height adjustable (standard)<br>Swing-away (option) | Identical |
| Controller Connector | Harness with in-line connector | Harness with in-line connector | Identical |
| USER INPUT CONTROLS | | | |
| Number of drive profiles | 5 | 5 | Identical |
| User input | Joystick and hand control buttons | Joystick and hand control buttons | Identical |
| On/off button | Yes | Yes | Identical |
| Speed up / speed down buttons | Yes | Yes | Identical |
| Horn button | Yes | Yes | Identical |
| Actuator control | Versions available with and without actuator control buttons | Versions available with and without actuator control buttons | Identical |
| Number of actuators for lift, tilt, recline | 2 | 6 - tilt, stand-up, recline (2), power legrests (2), lift. | Equivalent |
| Battery state indicator | LEDs | LEDs | Identical |
| Electronics package | Electronics in both hand control module and motor control module | Electronics in both hand control module and motor control module | Identical |
| Programming tool | Hand held<br>programmer | Hand held<br>programmer | Identical |
| External drive<br>inhibit input | Yes | Yes | Identical |
| Attendant control | Option with R-Net<br>system | Option with R-Net<br>system | Identical |
| Bluetooth PC<br>mouse replacement | Option with R-Net<br>system | Option with R-Net<br>system | Identical |

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#### Use of Standards

The table below (Table 4) provides a summary of all the various standards to which the Q700-UP M conforms.

Table 4. List of recognized standards to which the Q700-UP M Complies

| Recognized Standard | Outcome |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO 7176-1 [ANSI/RESNA WC-1/1]: Determination of Static<br>Stability | Pass |
| ISO 7176-2 [ANSI/RESNA WC-2/2]: Determination of Dynamic<br>Stability of Electrically Powered Wheelchairs | Pass |
| ISO 7176-3 [ANSI/RESNA WC-2/3]: Determination of<br>effectiveness of brakes | Pass |
| ISO 7176-4 [ANSI/RESNA WC-2/4]: Energy consumption of<br>electrically powered wheelchairs and scooters for determination<br>of theoretical distance | Pass |
| ISO 7176-5 [ANSI/RESNA WC-1/5]: Determination of<br>dimensions, mass and maneuvering space | Pass |
| ISO 7176-6 [ANSI/RESNA WC-2/6]: Determination of<br>maximum speed, acceleration and deceleration of electrically<br>powered wheelchairs | Pass |
| ISO 7176-7 [ANSI/RESNA WC-1/7]: Method of measurement<br>of seating and wheel dimensions | Pass |
| ISO 7176-8 [ANSI/RESNA WC-1/8]: Requirements and test<br>methods for static, impact and fatigue strengths | Pass |
| ISO 7176-9 [ANSI/RESNA WC-2/9]: Climatic tests for<br>electrically powered wheelchairs | Pass |
| ISO 7176-10 [ANSI/RESNA WC-2/10]: Determination of<br>obstacle-climbing ability of electrically powered wheelchairs | Pass |
| ISO 7176-14 [ANSI/RESNA WC-2/14]: Power and control<br>systems for electrically powered wheelchairs - Requirements<br>and test methods | Pass |
| ISO 7176-15 [ANSI/RESNA WC-1/15]: Requirements for<br>information disclosure, documentation and labeling | Pass |
| ISO 7176-16 [ANSI/RESNA WC-1/16]: Resistance to ignition of<br>upholstered parts - Requirements and test methods | Pass |

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| ISO 7176-19 [ANSI/RESNA WC-4/19]: Wheeled mobility<br>devices for use as seats in motor vehicles | Pass |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ISO 7176-21 [ANSI/RESNA WC-2/21]: Requirements and test<br>methods for electromagnetic compatibility of electrically<br>powered wheelchairs and motorized scooters | Pass |
| ISO 10993-5: Biological evaluation of medical devices | Pass |
| ISO 7176-25: Batteries and chargers for powered wheelchairs<br>and motorized scooters - Requirements and test methods | Pass |
| RESNA WC-1:2009 Section 20: Determination of the<br>Performance of Stand-up Type Wheelchairs | Pass |

#### Clinical Testing and/or Non-Clinical Testing

No Clinical Testing is required for this submission

#### Conclusion

All verification and validation testing conducted demonstrate that the Quickie® Q700-UP M is substantially equivalent to the primary predicate device:

| Primary Predicate Device: | Levo C3 Power Wheelchair<br>K083017<br>Product Code IPL<br>21 CFR 890.3900 |
|---------------------------|--------------------------------------------------------------------------------------|
| Reference Device: | Sunrise Medical Quickie® Pulse 6SC<br>K142457<br>Product Code ITI<br>21 CFR 890.3860 |