(272 days)
The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
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.
The provided document is a 510(k) summary for a medical device, specifically power scooters. It does not contain information about an AI/ML-driven medical device, nor does it detail acceptance criteria and a study proving an AI/ML device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance standards and comparisons of specifications.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves an AI/ML device meets acceptance criteria based on the provided text. The document discusses:
- Device Description: Power scooters (Quingo Classic, Flyte, Toura).
- Predicate Device: Merits Transformer, Model S941, K142162.
- Comparison Tables: Detailed comparisons of physical, electrical, and performance characteristics between the subject devices and the predicate device.
- Non-Clinical Tests: Adherence to various ISO, ANSI, BS EN, and IEC standards for wheelchairs and motorized three-wheeled vehicles (e.g., static stability, dynamic stability, brakes, energy consumption, dimensions, speed, strength, climatic tests, electromagnetic compatibility, ignition resistance).
- Clinical Tests: Stated as "Not applicable as there are no new indications for use which must be supported by a clinical data."
- Software Information: Mentions "Software validation was conducted in accordance with a major level of concern designation" but provides no details on the validation study itself.
None of this information pertains to the rigorous evaluation of an AI/ML device's performance against defined acceptance criteria, including aspects like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies for human-AI interaction.
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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
{1}------------------------------------------------
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) | X |
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510(k) SUMMARY
The assigned 510(k) number is: K170634
-
- Date Prepared: November 28, 2017
Submitter's Identification:
- Date Prepared: November 28, 2017
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
-
- Device Trade/Proprietary Name:
Advanced Vehicle Concepts Ltd. Quingo Classic Power Scooter, S1301, Quingo Flyte Power Scooter, S551, Quingo Toura Power Scooter, S350.
- Device Trade/Proprietary Name:
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
-
- Predicate Device:
Merits Health Products Co., Ltd., Merits Transformer, Model S941, K142162
- Predicate Device:
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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 | SUBJECTDEVICE | PREDICATEDEVICE | Safety &effectiveness ofsubject devicecompared to thepredicate device. |
|---|---|---|---|
| Brand Name | Classic | Merits Transformer | Different Make |
| Manufacturer | Advanced VehicleConcepts Ltd | Merits HealthProducts Co., Ltd. | SameManufacturer |
| ModelNumber | S1301 | S941 | Different Model |
| 510K No | K170634 | K142162 | DifferentSubmission |
| 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 Degrees23 Miles / 37 Kilometers | 10 Degrees25 Miles / 40 Kilometers | Safer SlopeSlightly 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 VehicleConcepts Ltd | Merits HealthProducts Co., Ltd. | SameManufacturer | |
| ModelNumber | S350 | S941 | Different Model | |
| 510K No | K170634 | K142162 | DifferentSubmission | |
| Series | Power MobilityScooter Series | Power MobilityScooter Series | Same | |
| Indications forUse | The devicesprovide mobility toadult personslimited to a sittingposition andcapable tooperate a fewsimple controls. | The devicesprovide mobility toadult personslimited to a sittingposition andcapable to operatea fewsimple controls. | Same Intendeduse and targetpopulation | |
| Warranty | 1 Year | 1 Year | Same | |
| Product Code | INI | INI | Same | |
| Weight Limit | 485 lbs. / 220 Kg | 350 lbs. / 159 Kg | Heavier Carrying/User WeightCapacity | |
| ElectronicsController | Dynamics Rhino 2DS160 | Dynamics Rhino 2DS120 | Same type withdifferent volumecontrollers | |
| Motor | DC 24V, 650 W | DC 24V, 400 W | Larger Power | |
| Footplates | AluminumAdjustableFootplates | ABS | IndividualAdjustablefootplates | |
| Suspension | FrontIntegral Lever ArmCoil SpringsRearIndependent CoilSprings | Integral Lever ArmCoil SpringsIndependent CoilSprings | Same | |
| BackUpholstery | Fabric | Fabric | Same Material | |
| Batteries | Quantity2 | 2 | Same Quantity | |
| Type12V, 100Ah | 12V, 50Ah | Larger Capacity | ||
| PatientContactingMaterials | Seat | Vinyl Fabric | Vinyl Fabric | Same |
| HandGrip | Rubber | Rubber | Same | |
| Seat Belt | Steel / ABS /Polyester Fabric | N/A (No Seat Belt) | Additional SafetyFeature | |
| OverallDimensions | OverallLength | 1390mm / 54" | 1300mm / 51.2" | Larger Length |
| OverallWidth | 670mm / 26.4" | 686mm / 27.2" | Smaller Width | |
| OverallHeight | 1430 / 56.3" | 1245mm / 49" | Higher Seatingposition | |
| ArmrestTypes | Removable & Flip-backward | Removable & Flip-backward | Same | |
| Frame | Steel Frame | Steel Frame | Same | |
| SeatDimensions | SeatWidth | 540mm / 21.3" | 470mm / 18" | Larger Width |
| SeatHeight(FromGround) | 720-790mm /28.3-33.1" | 635-685mm / 25-27" | Higher Seatingposition | |
| SeatDepth(Actual) | 470mm / 18.5" | 400mm / 16" | Larger Depth | |
| SeatHeight(FromDeck) | 520-590mm / 20.5-23.2" | 430-480mm / 17-19" | Higher Seatingposition | |
| Wheels | Front | 10" PneumaticTires | 12" PneumaticTires | Smaller size,same type |
| Front (2 xOuterWheels) | 9" Pu Tires | N/A | Extra (5 Wheeldesign) | |
| Rear(DriveWheels) | 12" PneumaticTires | 12" PneumaticTires | Smaller size,same type | |
| TurningRadius | 1320mm / 52" | 1670mm / 65.7" | Smaller turningcircle | |
| GroundClearance | 155mm / 6.1" | 90mm / 3.5" | Larger clearance | |
| Kerb ClimbingAbility | 100mm / 4" | 100mm / 4" | Same | |
| ScooterWeight | TotalUnlaiden | 361.3 lbs. / 163.9Kg | 118kg / 260 lbs. | Larger Weight |
| WithoutBatteries | 216.7 lbs. / 98.3Kg | 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 | SUBJECTDEVICE | PREDICATEDEVICE | Safety &effectiveness ofsubject devicecompared to thepredicate device. | ||
|---|---|---|---|---|---|
| Brand Name | Flyte | MeritsTransformer | Different Make | ||
| Manufacturer | AdvancedVehicleConcepts Ltd | Merits HealthProducts Co., Ltd. | Same Manufacturer | ||
| ModelNumber | S551 | S941 | Different Model | ||
| 510K No | K170634 | K142162 | Different Submission | ||
| Series | Power MobilityScooter Series | Power MobilityScooter Series | Same | ||
| Indications forUse | The devicesprovide mobilityto adult personslimited to a sittingposition andcapable tooperate a fewsimple controls. | The devicesprovide mobility toadult personslimited to a sittingposition andcapable to operatea fewsimple controls. | Same Intended useand targetpopulation | ||
| 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 | ||
| ElectronicsController | Dynamics Rhino 2 DS90 | Dynamics Rhino 2 DS120 | Same type with different volume controllers | ||
| Motor | DC 24V, 250 WAluminumAdjustableFootplates | 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 ArmCoil Springs | No suspension on subject device | |
| Rear | N/A | Independent CoilSprings | No suspension on subject device | ||
| BackUpholstery | Fabric | Fabric | Same Material | ||
| Batteries | Quantity | 4 | 2 | Greater QuantityLower amp ofbatteries in subject.Total amps issubject is 88ampagainst 100amps inpredicate | |
| Type | 12V, 22Ah | 12V, 50Ah | |||
| PatientContactingMaterials | Seat | Vinyl Fabric | Vinyl Fabric | Same | |
| HandGrip | Rubber | Rubber | Same | ||
| Seat Belt | Steel/ ABS/Polyester Fabric | N/A (No Seat Belt) | Additional SafetyFeature | ||
| OverallDimensions | OverallLength | 1100mm / 43.3" | 1300mm / 51.2" | Smaller Length -more maneuverable | |
| OverallWidth | 590mm / 23.2" | 686mm / 27.2" | Smaller Width -more maneuverable | ||
| OverallHeight | 1010mm / 39.8" | 1245mm / 49" | Smaller in Length toassistmaneuverability | ||
| ArmrestTypes | Removable &Flip-backward | Removable & Flip-backward | Same | ||
| Frame | Steel Frame | Steel Frame | Same | ||
| SeatDimensions | SeatWidth | 410mm / 16" | 470mm / 18" | Smaller Width | |
| SeatHeight(FromGround) | 710mm / 28" | 635-685mm / 25-27" | Higher Seatingposition | ||
| SeatDepth(Actual) | 380mm / 14.9" | 400mm / 16" | Smaller Depth | ||
| SeatHeight(FromDeck) | 500m / 19.7" | 430-480mm / 17-19" | Higher Seatingposition | ||
| Wheels | Front | 10" PneumaticTires | 12" PneumaticTires | ||
| Front (2 xOuterWheels) | 7" Pu Tires | N/A | Extra (5 Wheeldesign) | ||
| Rear(DriveWheels) | 10" PneumaticTires | 12" PneumaticTires | Smaller size | ||
| TurningRadius | 1020mm / 40.2" | 1670mm / 65.7" | Smaller turningRadius | ||
| GroundClearance | 127mm / 5" | 90mm / 3.5" | Larger ability | ||
| Kerb ClimbingAbility | 76mm / 3" | 100mm / 4" | Slightly lessclearance | ||
| ScooterWeight | TotalUnlaiden | 257 lbs / 116.5Kg | 118kg / 260 lbs | Lower Weight | |
| WithoutBatteries | N/A | 84kg / 185 lbs | Still Lower on weight | ||
| MaximumSpeed | 4 Mph / 6.4 Kph | 7.5 mph / 12 Kph | Lower max speed | ||
| Incline /Gradient | 6 Degrees | 10 Degrees | Smaller angle | ||
| Range (upto) | 23 Miles / 37Kilometers | 25 Miles / 40Kilometers | Slightly less range | ||
| BatteryCharger | Type | External (off-board) Charger | External (off-board) Charger | Same | |
| VoltageOutput | 24 VDC, 5Ah | 24 VDC, 5Ah | Same type | ||
| Model | HP8204-5A | HP8204B-5A | Same Manufacturer |
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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 wheelchairs
16-196 ISO 7176-7 First Edition 1998-05-15:- Wheelchairs - Part 7: Measurement of seating and wheel dimensions
16-197 ISO 7176-8 Second edition 2014-12-15:- Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths
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16-167 ISO 7176-9: Third edition 2009-11-15:- Wheelchairs - Part 9: Climatic tests for electric wheelchairs
16-164 ISO 7176-10 Second edition 2008-11-01:- Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
16-190 ISO 7176-11 Second edition 2012-12-01:- Wheelchairs - Part 11: Test dummies
16-25 ISO 7176-13 First edition 1989-08-01:- Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
16-165 ISO 7176-14 Second edition 2008-02-15:- Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
16-191 ISO 7176-16 Second edition 2012-12-01:- Wheelchairs - Part 16: Resistance to ignition of postural support devices
16-166 ISO 7176-21 Second edition 2009-04-01:- Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
16-198 ISO 7176-22 Second edition 2014-09-01:- Wheelchairs - Part 22: Set-up procedures
16-194 ISO 7176-25 First edition 2013-07-15:- Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
16-187 ANSI RESNA WC-1:2009- American National Standard for Wheelchairs - Volume 1 :- Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
ISO 9001:2008:- Requirements for a quality management system
ISO 13485:2003 + AC: 2007:- Medical devices -- Quality management systems --Requirements for regulatory purposes
5-40: ISO 14971 Second Edition 2007-03-01:- Medical Devices - Application of Risk Management to Medical Devices. (General I (QS/RM))
BS EN 1041:2008:- Information supplied by the manufacturer of medical devices
BS EN 12184:2014:- Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
BS EN 12182:1999 Technical aids for disabled persons. General requirements and test methods
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IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. (General II (ES/EMC))
EN 55011:2007 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
BS EN 1021-1/2: 2006 Fire Test to Upholstered Furniture
8. Discussion of Clinical Tests Performed:
Not applicable as there are no new indications for use which must be supported by a clinical data.
9. Software Information:
Software validation was conducted in accordance with a major level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
10. Conclusions:
Conclusions drawn from the performance, bench and non-clinical tests demonstrate that the subject devices are as safe, effective and perform as well as the predicate devices.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).