Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and electrical components and control mechanisms, with no mention of AI or ML. The performance studies reference a guidance document for mechanical and powered wheelchairs, further indicating a lack of AI/ML components.

Therapeutic

No
The device is a mobility aid for adults limited to a sitting position, providing transportation rather than treating or diagnosing a medical condition.

Diagnostic

No

The device description indicates that the Quingo models are power scooters designed to provide mobility for adult persons. There is no mention of the device being used to diagnose any medical condition or to collect any diagnostic data.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components such as a welded steel frame, wheels, motor, transaxle, brakes, batteries, and a tiller. It describes a physical power scooter, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to "provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls." This describes a device for physical assistance and mobility, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description details a power scooter with mechanical and electrical components for movement and control. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.

The device described is clearly a mobility aid, falling under a different regulatory category than IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The devices provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

Product codes

INI

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 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult persons.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were performed 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". Testing met all relevant requirements and demonstrated no design characteristics that violated the requirements or resulted in any safety hazards.

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

Not Found

Predicate Device(s)

K142162

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

2

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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3

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

1. 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

1. Predicate Device:
  Merits Health Products Co., Ltd., Merits Transformer, Model S941, K142162

4

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.

5

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.

6

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.

7

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
DEVICE | PREDICATE
DEVICE | Safety &
effectiveness of
subject device
compared to the
predicate device. |
|-----------------|----------------------------------|-------------------------------------|----------------------------------------------------------------------------------------|
| Brand Name | Classic | Merits Transformer | Different Make |
| Manufacturer | Advanced Vehicle
Concepts Ltd | Merits Health
Products Co., Ltd. | Same
Manufacturer |
| Model
Number | S1301 | S941 | Different Model |
| 510K No | K170634 | K142162 | Different
Submission |
| Series | Power Mobility | Power Mobility | Same |

8

	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
23 Miles / 37 Kilometers	10 Degrees
25 Miles / 40 Kilometers	Safer Slope
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

9

10

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
Concepts Ltd	Merits Health
Products Co., Ltd.	Same
Manufacturer
Model
Number	S350	S941	Different Model
510K No	K170634	K142162	Different
Submission
Series	Power Mobility
Scooter Series	Power Mobility
Scooter Series	Same
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	485 lbs. / 220 Kg	350 lbs. / 159 Kg	Heavier Carrying/
User Weight
Capacity
Electronics
Controller	Dynamics Rhino 2
DS160	Dynamics Rhino 2
DS120	Same type with
different volume
controllers
Motor	DC 24V, 650 W	DC 24V, 400 W	Larger Power
Footplates	Aluminum
Adjustable
Footplates	ABS	Individual
Adjustable
footplates
Suspension	Front
Integral Lever Arm
Coil Springs
Rear
Independent Coil
Springs	Integral Lever Arm
Coil Springs
Independent Coil
Springs	Same
Back
Upholstery	Fabric	Fabric	Same Material
Batteries	Quantity
2	2	Same Quantity
	Type
12V, 100Ah	12V, 50Ah	Larger 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	1390mm / 54"	1300mm / 51.2"	Larger Length
	Overall
Width	670mm / 26.4"	686mm / 27.2"	Smaller Width
	Overall
Height	1430 / 56.3"	1245mm / 49"	Higher Seating
position
Armrest
Types		Removable & Flip-
backward	Removable & Flip-
backward	Same
Frame		Steel Frame	Steel Frame	Same
Seat
Dimensions	Seat
Width	540mm / 21.3"	470mm / 18"	Larger Width
	Seat
Height
(From
Ground)	720-790mm /
28.3-33.1"	635-685mm / 25-
27"	Higher Seating
position
	Seat
Depth
(Actual)	470mm / 18.5"	400mm / 16"	Larger Depth
	Seat
Height
(From
Deck)	520-590mm / 20.5-
23.2"	430-480mm / 17-
19"	Higher Seating
position
Wheels	Front	10" Pneumatic
Tires	12" Pneumatic
Tires	Smaller size,
same type
	Front (2 x
Outer
Wheels)	9" Pu Tires	N/A	Extra (5 Wheel
design)
	Rear
(Drive
Wheels)	12" Pneumatic
Tires	12" Pneumatic
Tires	Smaller size,
same type
Turning
Radius		1320mm / 52"	1670mm / 65.7"	Smaller turning
circle
Ground
Clearance		155mm / 6.1"	90mm / 3.5"	Larger clearance
Kerb Climbing
Ability		100mm / 4"	100mm / 4"	Same
Scooter
Weight	Total
Unlaiden	361.3 lbs. / 163.9
Kg	118kg / 260 lbs.	Larger Weight
	Without
Batteries	216.7 lbs. / 98.3
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

11

12

COMPARISON OF SUBJECT DEVICE (QUINGO FLYTE) AND PREDICATE DEVICE (Merits Transformer K142162)

| ITEMS | SUBJECT
DEVICE | PREDICATE
DEVICE | Safety &
effectiveness of
subject device
compared to the
predicate device. | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Brand Name | Flyte | Merits
Transformer | Different Make | | |
| Manufacturer | Advanced
Vehicle
Concepts Ltd | Merits Health
Products Co., Ltd. | Same Manufacturer | | |
| Model
Number | S551 | S941 | Different Model | | |
| 510K No | K170634 | K142162 | Different Submission | | |
| Series | Power Mobility
Scooter Series | Power Mobility
Scooter Series | Same | | |
| 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/ User Weight Capacity | | |
| Electronics
Controller | Dynamics Rhino 2 DS90 | Dynamics Rhino 2 DS120 | Same type with different volume controllers | | |
| Motor | DC 24V, 250 W
Aluminum
Adjustable
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
Coil Springs | No suspension on subject device | |
| | Rear | N/A | Independent Coil
Springs | No suspension on subject device | |
| Back
Upholstery | Fabric | Fabric | Same Material | | |
| Batteries | Quantity | 4 | 2 | Greater Quantity
Lower amp of
batteries in subject.
Total amps is
subject is 88amp
against 100amps in
predicate | |
| | Type | 12V, 22Ah | 12V, 50Ah | | |
| 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 | 1100mm / 43.3" | 1300mm / 51.2" | Smaller Length -
more maneuverable | |
| | Overall
Width | 590mm / 23.2" | 686mm / 27.2" | Smaller Width -
more maneuverable | |
| | Overall
Height | 1010mm / 39.8" | 1245mm / 49" | Smaller in Length to
assist
maneuverability | |
| Armrest
Types | | Removable &
Flip-backward | Removable & Flip-
backward | Same | |
| Frame | | Steel Frame | Steel Frame | Same | |
| Seat
Dimensions | Seat
Width | 410mm / 16" | 470mm / 18" | Smaller Width | |
| | Seat
Height
(From
Ground) | 710mm / 28" | 635-685mm / 25-
27" | Higher Seating
position | |
| | | | | | |
| | Seat
Depth
(Actual) | 380mm / 14.9" | 400mm / 16" | Smaller Depth | |
| | | Seat
Height
(From
Deck) | 500m / 19.7" | 430-480mm / 17-
19" | Higher Seating
position |
| | | Wheels | Front | 10" Pneumatic
Tires | 12" Pneumatic
Tires |
| | | 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 | | 1020mm / 40.2" | 1670mm / 65.7" | Smaller turning
Radius | |
| Ground
Clearance | | 127mm / 5" | 90mm / 3.5" | Larger ability | |
| Kerb Climbing
Ability | | 76mm / 3" | 100mm / 4" | Slightly less
clearance | |
| Scooter
Weight | Total
Unlaiden | 257 lbs / 116.5
Kg | 118kg / 260 lbs | Lower Weight | |
| | Without
Batteries | N/A | 84kg / 185 lbs | Still Lower on weight | |
| Maximum
Speed | | 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 / 37
Kilometers | 25 Miles / 40
Kilometers | Slightly less range | |
| Battery
Charger | Type | External (off-
board) Charger | External (off-
board) Charger | Same | |
| | Voltage
Output | 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.