Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
Device Facts
| Record ID | K170634 |
|---|---|
| Device Name | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 |
| Applicant | Advanced Vehicle Concepts , Ltd. |
| Product Code | INI · Physical Medicine |
| Decision Date | Nov 29, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3800 |
| Device Class | Class 2 |
Indications for Use
The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Device Story
Quingo Classic (S1301), Toura (S350), and Flyte (S551) are battery-powered, three-wheeled mobility scooters with a five-wheel stabilizing system. Devices feature welded steel frames, rear transaxle drive, and a tiller-based steering mechanism. Operation involves a wig-wag throttle lever and speed control knob on the tiller. Activating the throttle signals the electronic controller (Dynamics Rhino 2 series) to release electromagnetic brakes; releasing the throttle automatically re-engages brakes to stop the scooter. An emergency/parking disc brake is located on the front middle wheel. Devices are intended for use by adults on dry, level surfaces like concrete or asphalt. They provide mobility assistance to users with limited physical capacity. Healthcare providers do not operate the device; it is for patient self-use.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing and performance standards, including ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic tests, obstacle climbing, power/control systems, EMC, and battery/charger safety).
Technological Characteristics
Welded steel frame; 24V DC motor/transaxle; electromagnetic and mechanical disc brakes; Dynamics Rhino 2 series electronic controllers (DS70C, DS90C, DS160); 12V lead-acid batteries; pneumatic tires; upholstery compliant with ISO 7176-16:2012 and BS EN 1021-1/2. Connectivity is limited to off-board battery charging via 3-pin microphone connector. Software is embedded firmware.
Indications for Use
Indicated for adult persons with limited mobility who are restricted to a sitting position and capable of operating simple controls.
Regulatory Classification
Identification
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Predicate Devices
- Merits Transformer, Model S941 (K142162)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2017
Advanced Vehicle Concepts Ltd. % Vaibhav A. Rajal Official Correspondent for Advanced Vehicle Concepts Ltd. mdi Consultants. Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K170634
Trade/Device Name: Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter S350 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: October 24, 2017 Received: October 25, 2017
Dear Mr. Rajal:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K170634
### Device Name
Advanced Vehicle Concepts Ltd. Quingo Classic Power Scooter, S1301, Quingo Flyte Power Scooter, S551, Quingo Toura Power Scooter, S350.
Indications for Use (Describe)
The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="text-decoration: overline;">X</span> |
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## 510(k) SUMMARY
The assigned 510(k) number is: K170634
- 1. Date Prepared: November 28, 2017
Submitter's Identification:
Contact Person: Mr. Mark Nicholls Advanced Vehicle Concepts Ltd. 7 Stadium Way Cradock Road Luton Bedfordshire LU4 OJF United Kingdom Tel: 44 1582 430889 Fax: 44 1582 430898 mark@quingoscooters.com
- 2. Device Trade/Proprietary Name:
Advanced Vehicle Concepts Ltd. Quingo Classic Power Scooter, S1301, Quingo Flyte Power Scooter, S551, Quingo Toura Power Scooter, S350.
Common Name: Motorized 3 Wheeled Vehicles (5 Wheeled Scooters)
Classification Name:
Regulation Number: 21 CFR Part 890.3800 Regulation Name: Motorized 3 Wheeled Vehicles (5 Wheeled Scooters) Regulatory Class: II Product Code: INI Classification Panel: Physical Medicine
- 3. Predicate Device:
Merits Health Products Co., Ltd., Merits Transformer, Model S941, K142162
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## 4. Device Description
There are three models in the Quingo range for this subject 510(k)
Quingo Flyte Power Scooter, S551 (transportable model), Quingo Classic Power Scooter, S1301 and Quingo Toura Power Scooter, S350 (pavement and higher speed models)
They all have very similar characteristics which are detailed below, with the main differences being: length, widths, motor size, controller size, and wheel size.
All the Quingo models scooter frames are a welded steel construction and they all include 2 rear wheels connected by a motor/ transaxle with an electromagnetic brake, batteries, and they all have 3 front wheels and a tiller to control its turning direction.
When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooters are allowed to move forwards or backward. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting to of the throttle lever. All the Quingo Models have an emergency parking brake, the lever for this brake is on the tiller and the brake itself is a carbon disc brake on to the front middle wheel.
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This is best illustrated by the picture below:
Image /page/5/Picture/1 description: The image shows a close-up of a five-wheel mobility scooter. The text above the scooter reads, "Agility: 5 Wheel Stabilizing System. Extra tight and dynamically safe turning." There is a green check mark with the word "YES!" next to it. There are also green arrows pointing in opposite directions below the scooter.
The Quingo Classic Power Scooter, S1301 is battery powered, rear transaxle driven and is controlled by the Dynamics Rhino 2 DS70C amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. The S1301 is powered by two 12 VDC 35ah batteries. The batteries are charged by a 5A off-board charger connect with 3-pin microphone connector to charging socket on the tiller. The approximate driving range on fully charged batteries is up to 37 kilometers (23 miles). The scooter frame is a welded steel construction and includes 2 rear wheels connected by a motor/transaxle with an electromagnetic brake, batteries, 3 front wheels and a tiller to control its turning direction.
When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forward or backwards. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting go of the throttle lever.
The S1301 also has fitted to the tiller, an emergency/parking brake which works via a disc brake on to one of the front wheels.
The upholstery of the device complies with ISO 7176-16:2012, resistance to ignition of postural support devices.
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The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The Quingo Toura Power Scooter, S350 is battery powered, rear transaxle driven and is controlled by the Dynamics Rhino 2 DS160 amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. The S350 is powered by two 12 VDC 100ah batteries. The batteries are charged by a 8A off-board charger connect with 3-pin microphone connector to charging socket on the tiller. The approximate driving range on fully charged batteries is up to 88 kilometers (55 miles). The scooter frame is a welded steel construction and includes 2 rear wheels connected by a motor/transaxle with an electromagnetic brake, batteries, 3 front wheels and a tiller to control its turning direction.
When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forward or backwards. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting go of the throttle lever.
The S350 also has fitted to the tiller, an emergency/parking brake which works via a disc brake on to one of the front wheels.
The upholstery of the device complies with ISO 7176-16:2012, resistance to iqnition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The Quinqo Flyte Power Scooter, S551 is battery powered, rear transaxle driven and is controlled by the Dynamics Rhino 2 DS90C amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. The S551 is powered by four 12 VDC 22ah batteries. The batteries are charged by a 5A off-board charger connect with 3-pin microphone connector to charging socket on the tiller. The approximate driving range on fully charged batteries is up to 37 kilometers (23 miles). The scooter frame is a welded steel construction and includes 2 rear wheels connected by a motor/transaxle with an electromagnetic brake, batteries, 3 front wheels and a tiller to control its turning direction.
When the user activates the throttle lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forward or backwards. When the user releases the throttle lever, the scooter slows to a stop and the brakes are automatically re-engaged. The electromechanical brakes allow the user to stop by letting go of the throttle lever.
The S551 also has fitted to the tiller, an emergency/parking brake which works via a disc brake on to one of the front wheels.
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The upholstery of the device complies with ISO 7176-16:2012, resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
# 5. Indications for Use:
The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
# 6. Comparison to the Predicate Device:
The Quingo Classic Power Scooter, S1301 is substantially equivalent to the Merits Transformer, Model S941, (K142162).
The Quingo Toura Power Scooter, S350 is substantially equivalent to the Merits Transformer, Model S941 (K142162).
The Quingo Flyte Power Scooter, S551 is substantially equivalent to the Merits Transformer, Model S941 (K142162).
Below are our "Comparison Tables" comparing the five subject device models to the predicate device:
# COMPARISON OF SUBJECT DEVICE (QUINGO CLASSIC) AND PREDICATE DEVICE (Merits Transformer K142162)
| ITEMS | SUBJECT<br>DEVICE | PREDICATE<br>DEVICE | Safety &<br>effectiveness of<br>subject device<br>compared to the<br>predicate device. |
|-----------------|----------------------------------|-------------------------------------|----------------------------------------------------------------------------------------|
| Brand Name | Classic | Merits Transformer | Different Make |
| Manufacturer | Advanced Vehicle<br>Concepts Ltd | Merits Health<br>Products Co., Ltd. | Same<br>Manufacturer |
| Model<br>Number | S1301 | S941 | Different Model |
| 510K No | K170634 | K142162 | Different<br>Submission |
| Series | Power Mobility | Power Mobility | Same |
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| | Scooter Series | Scooter Series | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------|
| Indications for Use | The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls. | The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls. | Same Intended use and target population | |
| Warranty | 1 Year | 1 Year | Same | |
| Product Code | INI | INI | Same | |
| Weight Limit | 350 lbs. / 159 Kg | 350 lbs. / 159 Kg | Same Carrying Capacity | |
| Electronics Controller | Dynamics Rhino 2 DS70C | Dynamics Rhino 2 DS120 | Same type with different volume controllers | |
| Motor | DC 24V, 250 W | DC 24V, 400 W | Smaller Motor (top speed is less on subject device) | |
| Footplates | Aluminum Adjustable Footplates | ABS | Individual Adjustable footplates ideal to stretch out legs | |
| Suspension | Front Lever Arm Coil Spring | Integral Lever Arm Coil Springs | Same | |
| | Rear Independent Coil Spring | Independent Coil Springs | Same | |
| Back Upholstery | Fabric | Fabric | Same Material | |
| Batteries | Quantity 2 | 2 | Same Quantity | |
| | Type 12V, 35Ah | 12V, 50Ah | Smaller Capacity | |
| Patient Contacting Materials | Seat Vinyl Fabric | Vinyl Fabric | Same | |
| | Hand Grip Rubber | Rubber | Same | |
| | Seat Belt Steel/ ABS/ Polyester Fabric | N/A (No Seat Belt) | Additional Safety Feature | |
| | | | | |
| Overall Dimensions | Overall Length 1220mm / 48" | 1300mm / 51.2" | Smaller Length | |
| | Overall Width 640mm / 25" | 686mm / 27.2" | Smaller width | |
| | Overall Height 900mm / 36" | 1245mm / 49" | Lower in overall height | |
| Armrest Types | Removable & Flip-backward | Removable & Flip-backward | Same | |
| Frame | Steel Frame | Steel Frame | Same | |
| Seat Dimensions | | | | |
| | Seat Width | 457mm / 18" | 470mm / 18" | Same |
| | Seat Height (From Ground) | 710mm / 28" | 635-685mm / 25-27" | Higher Seating position |
| | Seat Depth (Actual) | 400mm / 15.7" | 400mm / 16" | Marginally Smaller Depth |
| | Seat Height (From Deck) | 450-550m / 18-22" | 430-480mm / 17-19" | Higher Seating position |
| Wheels | | | | |
| | Front | 10" Pneumatic Tires | 12" Pneumatic Tires | Smaller size |
| | Front (2 x Outer Wheels) | 7" Pu Tires | N/A | Extra (5 Wheel design) |
| | Rear (Drive Wheels) | 10" Pneumatic Tires | 12" Pneumatic Tires | Smaller size |
| Turning Radius | | 1070mm / 42" | 1670mm / 65.7" | Smaller Radius making it easier to maneuver |
| Ground Clearance | | 127mm / 5" | 90mm / 3.5" | Larger clearance |
| Kerb Climbing Ability | | 76mm / 3" | 100mm / 4" | Slightly less kerb climbing ability |
| Scooter Weight | Total Unlaiden | 220 lbs. / 100 Kg | 118kg / 260 lbs. | Lower Weight |
| | Without Batteries | 170.2 lbs. / 77.2 Kg | 84kg / 185 lbs. | Lower Weight |
| Maximum Speed | | 4 Mph / 6.4 Kph | 7.5 mph / 12 Kph | Less Speed |
| Incline / Gradient | | 12 Degrees<br>23 Miles / 37 Kilometers | 10 Degrees<br>25 Miles / 40 Kilometers | Safer Slope<br>Slightly smaller range |
| Battery Charger | Type | External (off-board) Charger | External (off-board) Charger | Same manufacture |
| | Voltage Output | 24 VDC, 5Ah | 24 VDC, 5Ah | Same type, higher ampage |
| | Model | HP8204-5A | HP8204B-5A | Same Manufacturer |
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# COMPARISON OF SUBJECT DEVICE (QUINGO Toura) AND PREDICATE DEVICE (Merits Transformer K142162)
| ITEMS | SUBJECT DEVICE | REFERENCE DEVICE | Safety & effectiveness of subject device compared to the Reference device. | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------|
| Brand Name | Toura 2 | Merits Transformer | Different Make | |
| Manufacturer | Advanced Vehicle<br>Concepts Ltd | Merits Health<br>Products Co., Ltd. | Same<br>Manufacturer | |
| Model<br>Number | S350 | S941 | Different Model | |
| 510K No | K170634 | K142162 | Different<br>Submission | |
| Series | Power Mobility<br>Scooter Series | Power Mobility<br>Scooter Series | Same | |
| Indications for<br>Use | The devices<br>provide mobility to<br>adult persons<br>limited to a sitting<br>position and<br>capable to<br>operate a few<br>simple controls. | The devices<br>provide mobility to<br>adult persons<br>limited to a sitting<br>position and<br>capable to operate<br>a few<br>simple controls. | Same Intended<br>use and target<br>population | |
| Warranty | 1 Year | 1 Year | Same | |
| Product Code | INI | INI | Same | |
| Weight Limit | 485 lbs. / 220 Kg | 350 lbs. / 159 Kg | Heavier Carrying/<br>User Weight<br>Capacity | |
| Electronics<br>Controller | Dynamics Rhino 2<br>DS160 | Dynamics Rhino 2<br>DS120 | Same type with<br>different volume<br>controllers | |
| Motor | DC 24V, 650 W | DC 24V, 400 W | Larger Power | |
| Footplates | Aluminum<br>Adjustable<br>Footplates | ABS | Individual<br>Adjustable<br>footplates | |
| Suspension | Front<br>Integral Lever Arm<br>Coil Springs<br>Rear<br>Independent Coil<br>Springs | Integral Lever Arm<br>Coil Springs<br>Independent Coil<br>Springs | Same | |
| Back<br>Upholstery | Fabric | Fabric | Same Material | |
| Batteries | Quantity<br>2 | 2 | Same Quantity | |
| | Type<br>12V, 100Ah | 12V, 50Ah | Larger Capacity | |
| Patient<br>Contacting<br>Materials | Seat | Vinyl Fabric | Vinyl Fabric | Same |
| | Hand<br>Grip | Rubber | Rubber | Same |
| | Seat Belt | Steel / ABS /<br>Polyester Fabric | N/A (No Seat Belt) | Additional Safety<br>Feature |
| Overall<br>Dimensions | Overall<br>Length | 1390mm / 54" | 1300mm / 51.2" | Larger Length |
| | Overall<br>Width | 670mm / 26.4" | 686mm / 27.2" | Smaller Width |
| | Overall<br>Height | 1430 / 56.3" | 1245mm / 49" | Higher Seating<br>position |
| Armrest<br>Types | | Removable & Flip-<br>backward | Removable & Flip-<br>backward | Same |
| Frame | | Steel Frame | Steel Frame | Same |
| Seat<br>Dimensions | Seat<br>Width | 540mm / 21.3" | 470mm / 18" | Larger Width |
| | Seat<br>Height<br>(From<br>Ground) | 720-790mm /<br>28.3-33.1" | 635-685mm / 25-<br>27" | Higher Seating<br>position |
| | Seat<br>Depth<br>(Actual) | 470mm / 18.5" | 400mm / 16" | Larger Depth |
| | Seat<br>Height<br>(From<br>Deck) | 520-590mm / 20.5-<br>23.2" | 430-480mm / 17-<br>19" | Higher Seating<br>position |
| Wheels | Front | 10" Pneumatic<br>Tires | 12" Pneumatic<br>Tires | Smaller size,<br>same type |
| | Front (2 x<br>Outer<br>Wheels) | 9" Pu Tires | N/A | Extra (5 Wheel<br>design) |
| | Rear<br>(Drive<br>Wheels) | 12" Pneumatic<br>Tires | 12" Pneumatic<br>Tires | Smaller size,<br>same type |
| Turning<br>Radius | | 1320mm / 52" | 1670mm / 65.7" | Smaller turning<br>circle |
| Ground<br>Clearance | | 155mm / 6.1" | 90mm / 3.5" | Larger clearance |
| Kerb Climbing<br>Ability | | 100mm / 4" | 100mm / 4" | Same |
| Scooter<br>Weight | Total<br>Unlaiden | 361.3 lbs. / 163.9<br>Kg | 118kg / 260 lbs. | Larger Weight |
| | Without<br>Batteries | 216.7 lbs. / 98.3<br>Kg | 84kg / 185 lbs. | Larger Weight |
| Maximum Speed | 6 Mph / 12.9 Kph | 7.5 mph / 12 Kph | Larger speed | |
| Incline / Gradient | 12 Degrees | 10 Degrees | Safer Slope | |
| Range (upto) | 55 Miles / 88 Kilometers | 25 Miles / 40 Kilometers | Larger range | |
| Battery Charger | Type | External (off-board) Charger | External (off-board) Charger | Same |
| | Voltage Output | 24 VDC, 8Ah | 24 VDC, 5Ah | Same type, higher ampage |
| | Model | 4C24080A | HP8204B-5A | Different type |
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# COMPARISON OF SUBJECT DEVICE (QUINGO FLYTE) AND PREDICATE DEVICE (Merits Transformer K142162)
| ITEMS | SUBJECT<br>DEVICE | PREDICATE<br>DEVICE | Safety &<br>effectiveness of<br>subject device<br>compared to the<br>predicate device. | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Brand Name | Flyte | Merits<br>Transformer | Different Make | | |
| Manufacturer | Advanced<br>Vehicle<br>Concepts Ltd | Merits Health<br>Products Co., Ltd. | Same Manufacturer | | |
| Model<br>Number | S551 | S941 | Different Model | | |
| 510K No | K170634 | K142162 | Different Submission | | |
| Series | Power Mobility<br>Scooter Series | Power Mobility<br>Scooter Series | Same | | |
| Indications for<br>Use | The devices<br>provide mobility<br>to adult persons<br>limited to a sitting<br>position and<br>capable to<br>operate a few<br>simple controls. | The devices<br>provide mobility to<br>adult persons<br>limited to a sitting<br>position and<br>capable to operate<br>a few<br>simple controls. | Same Intended use<br>and target<br>population | | |
| Warranty | 1 Year | 1 Year | Same | | |
| Product Code | INI | INI | Same | | |
| Weight Limit | 350 lbs. / 159 Kg | 350 lbs. / 159 Kg | Same Carrying/ User Weight Capacity | | |
| Electronics<br>Controller | Dynamics Rhino 2 DS90 | Dynamics Rhino 2 DS120 | Same type with different volume controllers | | |
| Motor | DC 24V, 250 W<br>Aluminum<br>Adjustable<br>Footplates | DC 24V, 400 W | Less Power due to lower max speed on the Subject device | | |
| Footplates | Footplates | ABS | Individual Adjustable footplates | | |
| Suspension | Front | N/A | Integral Lever Arm<br>Coil Springs | No suspension on subject device | |
| | Rear | N/A | Independent Coil<br>Springs | No suspension on subject device | |
| Back<br>Upholstery | Fabric | Fabric | Same Material | | |
| Batteries | Quantity | 4 | 2 | Greater Quantity<br>Lower amp of<br>batteries in subject.<br>Total amps is<br>subject is 88amp<br>against 100amps in<br>predicate | |
| | Type | 12V, 22Ah | 12V, 50Ah | | |
| Patient<br>Contacting<br>Materials | Seat | Vinyl Fabric | Vinyl Fabric | Same | |
| | Hand<br>Grip | Rubber | Rubber | Same | |
| | Seat Belt | Steel/ ABS/<br>Polyester Fabric | N/A (No Seat Belt) | Additional Safety<br>Feature | |
| Overall<br>Dimensions | Overall<br>Length | 1100mm / 43.3" | 1300mm / 51.2" | Smaller Length -<br>more maneuverable | |
| | Overall<br>Width | 590mm / 23.2" | 686mm / 27.2" | Smaller Width -<br>more maneuverable | |
| | Overall<br>Height | 1010mm / 39.8" | 1245mm / 49" | Smaller in Length to<br>assist<br>maneuverability | |
| Armrest<br>Types | | Removable &<br>Flip-backward | Removable & Flip-<br>backward | Same | |
| Frame | | Steel Frame | Steel Frame | Same | |
| Seat<br>Dimensions | Seat<br>Width | 410mm / 16" | 470mm / 18" | Smaller Width | |
| | Seat<br>Height<br>(From<br>Ground) | 710mm / 28" | 635-685mm / 25-<br>27" | Higher Seating<br>position | |
| | | | | | |
| | Seat<br>Depth<br>(Actual) | 380mm / 14.9" | 400mm / 16" | Smaller Depth | |
| | | Seat<br>Height<br>(From<br>Deck) | 500m / 19.7" | 430-480mm / 17-<br>19" | Higher Seating<br>position |
| | | Wheels | Front | 10" Pneumatic<br>Tires | 12" Pneumatic<br>Tires |
| | | Front (2 x<br>Outer<br>Wheels) | 7" Pu Tires | N/A | Extra (5 Wheel<br>design) |
| | Rear<br>(Drive<br>Wheels) | 10" Pneumatic<br>Tires | 12" Pneumatic<br>Tires | Smaller size | |
| Turning<br>Radius | | 1020mm / 40.2" | 1670mm / 65.7" | Smaller turning<br>Radius | |
| Ground<br>Clearance | | 127mm / 5" | 90mm / 3.5" | Larger ability | |
| Kerb Climbing<br>Ability | | 76mm / 3" | 100mm / 4" | Slightly less<br>clearance | |
| Scooter<br>Weight | Total<br>Unlaiden | 257 lbs / 116.5<br>Kg | 118kg / 260 lbs | Lower Weight | |
| | Without<br>Batteries | N/A | 84kg / 185 lbs | Still Lower on weight | |
| Maximum<br>Speed | | 4 Mph / 6.4 Kph | 7.5 mph / 12 Kph | Lower max speed | |
| Incline /<br>Gradient | | 6 Degrees | 10 Degrees | Smaller angle | |
| Range (upto) | | 23 Miles / 37<br>Kilometers | 25 Miles / 40<br>Kilometers | Slightly less range | |
| Battery<br>Charger | Type | External (off-<br>board) Charger | External (off-<br>board) Charger | Same | |
| | Voltage<br>Output | 24 VDC, 5Ah | 24 VDC, 5Ah | Same type | |
| | Model | HP8204-5A | HP8204B-5A | Same Manufacturer | |
{13}------------------------------------------------
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### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the subject device in the intended environment of use is supported by testing that was conducted in accordance with the FDA July 26, 1995 Draft, Reformatted 12/18/97, "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorize Three-Wheeled Vehicles".
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was Advanced Vehicle Concepts Ltd.'s conclusion that testing met all relevant requirements of "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorize Three-Wheeled Vehicles".
The following National and International Standards were utilized for testing the subject devices, which established substantial equivalence between the subject devices and the predicate devices:
## Performance Standards:
16-195 ISO 7176-1 Third edition 2014-10-01:- Wheelchairs - Part 1: Determination of static stability
16-159 ISO 7176-2 Second edition 2001-06-15:- Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
16-192 ISO 7176-3 Third edition 2012-12-15: - Wheelchairs - Part 3: Determination of effectiveness of brakes
16-162 ISO 7176-4 Third edition 2008-10-01:- Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
16-163 ISO 7176-5 Second edition 2008-06-01:- Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
16-29 ISO 7176-6 Second edition 2001-10-01:- Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchair…
