(41 days)
Not Found
No
The description focuses on mechanical and electronic controls for mobility, with no mention of AI or ML capabilities.
No.
The device is described as an electric scooter designed for transportation, not for treating or preventing a disease or condition.
No
The Quingo Flyte is described as an electric scooter for transportation, not for diagnosing medical conditions. The "Intended Use" clearly states its purpose is to provide transportation to individuals with mobility limitations.
No
The device description clearly outlines a physical, battery-powered electric scooter with wheels, a seat, steering controls, and a charging unit. It is a hardware device designed for transportation.
Based on the provided information, the Quingo Flyte is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing transportation to individuals with mobility limitations. This is a mechanical function, not a diagnostic one.
- Device Description: The description details a battery-powered scooter with wheels, a seat, steering, and controls. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
- Testing and Standards: The testing mentioned (ISO 7176 standards) are related to wheelchairs and mobility devices, not IVD performance.
The Quingo Flyte is a mobility aid, falling under the category of durable medical equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.
Product codes
INI
Device Description
The Quingo Flyte Mobility Scooter is a battery powered indoor scooter. The vehicle uses a 5 (Five) wheel system comprised of 3 main wheels with two additional wheels to provide additional safety, stability and improved turning ability. Attached to the wheelbase are a padded seat, steering tiller, bars and electronic controls which allow the user to properly direct and control the vehicle.
As the vehicle is battery powered a charging unit is included. To assist with loading into vehicles for transport an aluminium railing system which fits into most vehicles is provided along with a directly wired electronic control so that no disassembly is required and no heavy lifting by the user is needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Agile Distributors LLC Steven Mahaffy Corporate Counsel 2283 East Zion Way Chandler, Arizona 85249
Re: K171256
Trade/Device Name: Quingo Flyte Mobility Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 21, 2017 Received: April 28, 2017
Dear Mr. Mahaffy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -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) K171256
Device Name Quingo Flyte Mobility Scooter
Indications for Use (Describe)
The Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) EXECUTIVE SUMMARY
| Submitter's Name: | Agile Distributors LLC
A Company incorporated in Arizona (Company Number L-1956314-4)
2283 East Zion Way,
Chandler,
AZ 85249
Tel: (480) 6597180 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Steven C Mahaffy |
| Date Summary Prepared: | 15th April 2015 (Modified 2nd August 2016) |
Device Names:
| Proprietary Name: | Quingo Flyte Mobility Scooter |
|---|---|
| Model Identity: | S551 (Flyte Configuration) |
| Common or Usual Name: | Electric Scooter |
| Classification: | Classification. Class II (performance standards) |
| Device Code: | INI |
| Classification Name: | Motorized Three-wheel Vehicle (890.3800) |
Predicate Device:
The legally marketed predicate device for substantial equivalence comparison is:
- . Kymco EQ 30, manufactured and distributed by Kwang Yang Motor Company Ltd., and cleared under 501(k) K072630
Description of the Device:
The Quingo Flyte Mobility Scooter is a battery powered indoor scooter. The vehicle uses a 5 (Five) wheel system comprised of 3 main wheels with two additional wheels to provide additional safety, stability and improved turning ability. Attached to the wheelbase are a padded seat, steering tiller, bars and electronic controls which allow the user to properly direct and control the vehicle.
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As the vehicle is battery powered a charging unit is included. To assist with loading into vehicles for transport an aluminium railing system which fits into most vehicles is provided along with a directly wired electronic control so that no disassembly is required and no heavy lifting by the user is needed.
Intended Use of Device:
The Quingo Flyte is an electric scooter designed to provide transportation to those with mobility limitations such as the disabled or elderly.
Substantial Equivalence
The Intended Use of the predicate device (Kymco ForU EQ30) is 'intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position'.
In terms of intended function and general operation this device is very similar to the Quingo Flyte with only minor technical differences that do not present any new questions regarding safe and effective use. Where the units do differ is the provision with the Quingo Flyte of a specific ramp accessory. We believe the provision of this ramp accessory, specifically designed for this unit to maximize safe loading and unloading into vehicles, is a safer option than untested generic ramp accessories that can be purchased for the Predicate and other devices on the open market without any safety or performance testing or FDA approval. The Quingo Flyte, while using the ramp accessory has been safety tested and the results provided with this application. Therefore, we believe the Quingo Flyte is substantially equivalent to this predicate and other legally marketed mobility scooters currently in distribution. See the product comparison table of vehicle features below for further details.
| Device & Predicate Device(s): | K171256 | K072630 |
|---|---|---|
| Manufacturer | Advanced Vehicle Concepts Ltd | Kwang Yang Motor Company Ltd |
| Model | Quingo Flyte Mobility Scooter | Kymco Super4 4U (EQ30BB) |
| Framework | Foldable | Rigid |
| Maximum User Weight | 350lbs | 330lbs |
| Length | 1110mm | 1250 |
| Width | 590mm | 560mm |
Product Comparison Table.
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| Height | 1050mm | 1250mm |
|---|---|---|
| Maximum Speed | 6.4 Kph/ 4 mph | 8 Kph/ 4.7 mph |
| Range Per Charge | 37 Km/ 23 Miles or 54 Km/ 34 miles | 37km or 23.1 miles |
| Wheel Size | 177.8mm (7") & 254mm (10") | 255mm (10") |
| Wheel Type | Solid & Pneumatic | Pneumatic |
| Heaviest Part | N/A (Vehicle Loads as One Unit) | 53lbs/24 Kg |
| Total Weight Inc. Batteries | 256.3lbs | 185.7lbs |
| Batteries | 22A x 4 / 22A x 6 | 36A |
| Range per Charge | 23 miles (4 batteries) | |
| 37 miles (6 batteries) | 23.1 mi | |
| Charger | 240 VAC input, 24V 6 Amp | |
| DC output | HP 24V, 5A on-board | |
| Seat Height | 515mm | 756mm |
| Lights Fitted | Yes | Yes |
| Maximum Slope - Degrees | ||
| (Rear Tip) | 6 | 10 |
| Turning Radius | 1020mm (40.2 inches) | 1565mm (61.6 inches) |
| Rated Motor Power | 250 Watt, 2 Pole | 350 Watt |
| Input Voltage | 24V | 24V |
| Brake System | Intelligent Regenerative | |
| Electromagnetic Brake & Hand Brake | Intelligent Regenerative | |
| Electromagnetic Brake & Hand Brake | ||
| Minimum braking distance - | ||
| Forward | 40 in | 48.8 in |
| Minimum braking distance - | ||
| Reverse | 40 in | Unknown |
| Ground clearance while | ||
| occupied | 4.72 Inches or 120mm | 2 Inches or 51mm |
| Controller | Rhino 2 DS 90 | KYSA 70 |
| Rear Wheel Drive | Sealed Transaxle Direct Drive | Sealed Transaxle Direct Drive |
| Battery Type | Sealed gel | Lead Acid |
| Anti Tip Wheels | Yes - Powered Anti-Tip - Anti Curb Trap | |
| Wheels | Yes | |
| Suspension | No | Rear only |
| Operation Mode | Thumb Operated Potentiometer | |
| Throttle Control | Thumb Operated Potentiometer | |
| Throttle Control | ||
| Battery Charger | Automatic Off Board SA | Automatic Off Board SA |
| Adaptive Footplates | Yes | No |
| Armrest | Yes - Adjustable | Yes |
| Tiller | Yes Foldable | Yes Foldable |
| Front Wheels | 7"x2.5" Solid tyres | 10"x5" Pneumatic tyres |
| Rear Wheels | 10"x5" Pneumatic tyres | 10"x5" Pneumatic tyres |
| Warning Horn | Yes | Yes |
| Speed Control | Single Mode - Variable (By | |
| potentiometer) | Single Mode - Variable (By | |
| potentiometer) | ||
| Braking Distance Full Speed | ||
| (Forward and Backward) | 40" | 48.8" |
| Bumpers | Yes. Steel Tube with Spring Suspension | Yes. Steel Tube |
| Maximum Curb Height | 3" | 3.14" |
| Battery Indicator Level | Yes | Yes |
| Docking Station | ||
| Speed up/down the ramp | 1 mph | N/A |
| Overall weight | 83.6 lbs. | N/A |
| Side ramp weight (each side) | 27.8 lbs. | N/A |
| Center ramp weight | 6 lbs. | N/A |
| Frame weight (including side | ||
| support arms) | 22 lbs. | N/A |
| Overall length (with supports) | 53.2 in | N/A |
| Folded length | 48.5 in | N/A |
| Overall width | 30.3 in | N/A |
| Height | 7.5 in | N/A |
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Technological Characteristics:
This device is very similar to the predicate device and other electric scooters that have been cleared under 510(k) in that it comprises of a single drive shaft, regenerative automatic brakes, steering tiller with electronic controls and fire resistant padded seating. The unit, as with most models can be disassembled for transport but in the case of this particular model, accessories in the form of an aluminium rail loading system that can be mounted into certain vehicle types and a physically wired (not wireless) remote control is provided to enable safe loading of the model without any disassembly or lifting.
Testing Conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results in the submission. The unit was tested in accordance with ISO 7176 Parts 1-11, 13, 14, 16, 19, 21, 22, 25 & 26 and was found compliant.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
Conclusion:
Review and evaluation of predicate device data and information provided in this 510(k) submission lead us to conclude that this device is substantially equivalent to the predicate device and that neither the device nor supplied accessories create any new safety or performance concerns.