(275 days)
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
Motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance. It is available in multiple models with varying specifications for wheels, size, weight capacity, speed, and travel distance. It uses dynamic braking and electromagnetic brake systems and is powered by SLA or Lithium batteries with an off-board charger.
The provided text describes a submission for a 510(k) premarket notification for a motorized vehicle called "SupaScoota." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a novel medical device AI/ML algorithm.
Therefore, many of the requested elements for describing acceptance criteria and the study that proves the device meets them (especially those related to AI/ML performance, ground truth, expert adjudication, and comparative effectiveness studies) are not applicable to this document. The document describes a traditional medical device submission for a physical product (a motorized vehicle).
However, I can extract information related to the device's performance and the testing conducted to ensure its safety and effectiveness based on the provided text.
Here's a breakdown of the relevant information:
Device: "SupaScoota" Motorized Vehicle
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for each performance metric in the same manner one might expect for an AI/ML algorithm. Instead, it relies on a comparison to predicate devices and compliance with international standards (ISO 7176 series). The performance metrics listed are descriptive specifications of the device.
| Performance Metric | Reported Device Performance (SupaScoota) | Implied Acceptance Criteria (based on comparison to predicates and ISO standards) |
|---|---|---|
| Physical Characteristics | ||
| Number of wheels | 3 wheels + 2 stabilizer wheels / 4 wheels (varies by model) | Comparable to predicate devices (FR168-3A3 and HEARTWAY S11 have 3 or 4 wheels) |
| Front wheel size | 200 x 65 mm (8"x2.5") / 200 x 50 mm (8"x2") | Comparable to predicate devices (e.g., HEARTWAY S11: 240 x 75 mm, FREERIDER FR168-3A3: 200 x 50 mm) |
| Rear wheel size | 200 x 65 mm (8"x2.5") / 260 x 85mm (10"x3") | Comparable to predicate devices (e.g., FREERIDER FR168-3A3: 200 x 50 mm) |
| Ground clearance | 60-65 mm (2.4-2.6") | Comparable to predicate devices (e.g., HEARTWAY S11: 70 mm, FREERIDER FR168-3A3: 86 mm) |
| Length | 945-1100 mm (37-43") | Comparable to predicate devices (e.g., HEARTWAY S11: 1070 mm, FREERIDER FR168-3A3: 945 mm) |
| Width | 550-600 mm (22-26") | Comparable to predicate devices (e.g., HEARTWAY S11: 580 mm, FREERIDER FR168-3A3: 508 mm) |
| Max Loading (weight capacity) | 80-125 kg (175-275 lbs) | Comparable to predicate devices (e.g., HEARTWAY S11: 120 kg, FREERIDER FR168-3A3: 110 kg) |
| Weight w/battery | 27.3-42.6 kg (60-94 lbs) | Comparable to predicate devices (e.g., HEARTWAY S11: 58 kg) |
| Turn Radius | 780-975 mm | Comparable to predicate devices (e.g., HEARTWAY S11: 1980 mm, FREERIDER FR168-3A3: 820 mm) |
| Functional Performance | ||
| Brakes | Dynamic braking and electromagnetic brake | Functional similar to predicate devices, and in compliance with ISO 7176-3 (Efficiency of brakes tests) |
| Motor Output | 1 x 180W / 2 x 150 W / 2 x 180 W | Comparable to predicate devices (e.g., HEARTWAY S11: 400 Watt), and in compliance with ISO 7176-14 (Power and control system) |
| Battery | SLA: 12V-20ah/ 24V-15ah; Lithium: 12V-20ah/ 24V-15ah | Comparable to predicate devices (e.g., HEARTWAY S11: 12V-22ah x 2, FREERIDER FR168-3A3: 24V 12ah) |
| Max Speed | 6.5 kph (4 mph) / 9.0 kph (5.6 mph) | Comparable to predicate devices (e.g., HEARTWAY S11: 8 kph, FREERIDER FR168-3A3: 6.5 kph), and in compliance with ISO 7176-6 (Maximum speed tests) |
| Travel Distance | SLA: 13-18 km (8-11 miles); Lithium: 16-22 km (10-13.6 miles) | Comparable to predicate devices (e.g., HEARTWAY S11: 20 km, FREERIDER FR168-3A3: 16 km), and in compliance with ISO 7176-4 (Theoretical distance) |
| Climbing angle | 8-12 Degrees | Comparable to predicate devices (e.g., HEARTWAY S11: 10 Degrees), and in compliance with ISO 7176-10 (Obstacle-climbing ability tests) |
| Safety and Other | Compliance with ISO 7176-1 (Static stability), ISO 7176-2 (Dynamic stability) | |
| Stability | ||
| EMC | Compliance with ISO 7176-21 (EMC test) and EN 12184 | |
| Fatigue Strengths | Compliance with ISO 7176-8 (Static, impact and fatigue strengths tests) |
2. Sample sized used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects. The testing described is non-clinical, primarily focusing on engineering and performance standards for the physical device. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) is not directly applicable in this context. The tests are conducted on the device models themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are concepts typically associated with AI/ML algorithms, especially for diagnostic or prognostic tasks. For this physical device, "ground truth" is established by direct physical measurements, engineering principles, and adherence to international performance standards (ISO 7176 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there's no diagnostic or interpretative task by human experts being evaluated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The "standalone" performance refers to the device's physical capabilities as tested against ISO standards.
7. The type of ground truth used
For the safety and effectiveness testing of the "SupaScoota" Motorized Vehicle, the "ground truth" is established by:
- International Standards: Compliance with the ISO 7176 series standards (e.g., static stability, dynamic stability, brake efficiency, theoretical distance range, maximum speed, climbing angle, EMC). These standards define measurable performance requirements.
- Engineering Specifications and Measurements: Direct physical measurements and tests of the device's technical characteristics (e.g., wheel size, weight, dimensions, motor output, battery capacity).
- Comparison to Predicate Devices: The key argument for substantial equivalence relies on comparing the "SupaScoota"'s characteristics and performance to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Eurogreen International Inc David Hsieh General Manager No.48, Ln.220, Sec.1, Fuzun Rd., Yuanlin Township Changhua County, 51055 Taiwan
Re: K143557
Trade/Device Name: "SupaScoota" Motorized Vehicle Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 10, 2015 Received: August 12, 2015
Dear Mr. Hsieh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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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.
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 yours,
Michael J.Hoffmann -S
Carlos L. Peña, PhD, MS for 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) K143557
Device Name "SupaScoota" Motorized Vehicle
Indications for Use (Describe)
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
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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| SupnScoot^ |
|---|
| ------------ |
Date of preparation : Aug. 07, 2015
5.1 Applicant Information
| Type of Submission | Original Application- Traditional 510(k) |
|---|---|
| Applicant Name | EUROGREEN INTERNATIONAL INC. |
| Address | No.48, Ln. 220, Sec. 1, Fuzun Rd., Yuanlin Township,Changhua County, Taiwan |
| Phone | +886-4-8319633 |
| Fax | +886-4-8332226 |
| Contact Person | David Hsieh |
| Contact Title | President |
| Contact E-mail | sales@lawia.com |
5.2 Device Description
Intended Use : As a motorized portable electric vehicle for indoor or
outside use by persons with medical conditions requiring assistance.
| Item | Description |
|---|---|
| Common Name | Motorized vehicle |
| Trade Name | "SupaScoota" Motorized vehicle |
| Classification Name | Motorized vehicle |
| Regulation Number | 890.3800 |
| Product Code | INI |
| Device Class | Class 2 |
| Model | STD01/ STD02/ HD01/ HD02/ SPC01/ SPC02/ |
| SP01/ SP02/ MD01/ MD02 |
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| SupnScootn |
|---|
| ------------ |
510(k) Summary
| Number of wheels | 3 wheels+2 stabilizer wheels |
|---|---|
| 4 wheels | |
| Front wheel size | 200 x 65 mm (8 x 2.5") |
| 200 x 50mm (8 x 2") | |
| Rear wheel size | 200 x 65 mm (8 x 2.5") |
| 260 x 85mm (10 x 3") | |
| Ground clearance | 60 |
| Length | 945 |
| Width | 550 |
| Height | 820mm (32")-930mm (36.6") |
| Seat height | 560mm (22")- 620mm (24.5") |
| Max Loading (weight capacity) | 80 |
| Weight without seat/ battery | 14.9 |
| Weight of Seat | 5.8 |
| (include seat frame & arm rest) | |
| Weight w/battery | 27.3 |
| Brakes | Dynamic braking and electromagnetic brake |
| Turn Radius | 780~975 mm |
| Motor Output | 1 x 180W/ 2 x 150 W/ 2 x 180 W |
| Battery | SLA: 12V-20ah/ 24V-15ah |
| Lithium: 12V-20ah/ / 24V-15ah | |
| On/off board battery chargers | Off board battery charger |
| Max Speed | 6.5 kph (4 mph)/ 9.0 kph (5.6 mph) |
| Travel Distance | SLA: 13 |
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| Image: SupaScoota logo | Section 5510(k) Summary | Page3 / 7 |
|---|---|---|
| Lithium: 16 | ||
| Climbing angle | 8~12 Degrees | |
| Steering wheels/drive wheels | 200mm (8") / 200mm (8")200mm (8") / 260mm (10") |
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4 / 7 Page 510(k) Summary Section 5
| Standard | Heavy Duty | Superior Duty | Sport | MD | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| STD01 | STD02 | HD01 | HD02 | SPC01 | SPC02 | SP01 | SP02 | MD01 | MD02 | |
| Number of wheels | 3 wheels +2stabilizerwheels | 4 wheels | 3 wheels+2stabilizerwheels | 4 wheels | 4 wheels | 4 wheels | 4 wheels | 4 wheels | 3 wheels+2stabilizerwheels | 4 wheels |
| Front wheel size | 200 x 65 mm(8x2.5") | 200 x 50 mm(8x2") | 200 x 65 mm(8x2.5") | 200 x 50 mm(8x2") | 200 x 65 mm(8x2.5") | 200 x 50 mm(8x2") | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") | 200 x 50 mm(8x2") |
| Rear wheel size | 200 x 65 mm(8x2.5") | 200 x 65 mm(8x2.5") | 200 x 65 mm(8x2.5") | 200 x 65 mm(8x2.5") | 200 x 65 mm(8x2.5") | 260 x 85mm (10 x 3") | 260 x 85mm (10 x 3") | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") | 200 x 65 mm(8x2.5") |
| Ground clearance | 60 mm (2.4") | 60 mm (2.4") | 60 mm (2.4") | 60 mm (2.4") | 60 mm (2.4") | 65 mm (2.6") | 65 mm (2.6") | 65 mm (2.6") | 60 mm (2.4") | 60 mm (2.4") |
| Length | 945 mm(37") | 1000 mm(39") | 970 mm(38") | 1010 mm(40") | 1000 mm(39") | 1040 mm(41") | 1100 mm (43") | 600 mm (24") | 945mm(37") | 1000mm(39") |
| Width | 550 mm(22") | 550 mm(22") | 570 mm(22.5") | 570 mm(22.5") | 570 mm(22.5") | 600 mm(24") | 600 mm (24") | 600 mm (24") | 570mm (22.5") | 570mm (22.5") |
| Max Loading | 80 kgs (175 lbs) | 80 kgs (175 lbs) | 125 kgs (275 lbs) | 125 kgs (275 lbs) | 105 kgs (230 lbs) | 125 kgs (275 lbs) | 125 kgs (275 lbs) | 125 kgs (275 lbs) | 125kg (275 lbs) | 125kg (275 lbs) |
| Weight without seat | 15.6 kgs(34.5 lbs) | 14.9 kgs (33 lbs) | 20.3 (44.5 lbs) | 19.8 kgs(43.5 lbs) | 17.8 kgs (39 lbs) | 19.5 kgs (44 lbs) | 21.9 kgs (48.5 lbs) | 21.9 kgs (48.5 lbs) | 17.7kg (39 lbs) | 18.6kg (41 lbs) |
| Weight of Seat | 5.8 kgs (13 lbs) | 5.8 kgs (13 lbs) | 7.7 kg (17 lbs) | 7.7 kg (17 lbs) | 5.8 kgs (13 lbs)(include seat frame & | 5.8 kgs (13 lbs)(include seat frame & | 8.6 kgs (19 lbs) | 11.5 kgs (25 lbs) | 5.8kg (13 lbs includedseat frame) | 5.8kg (13 lbs includedseat frame) |
5-4
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| Suposcoota |
|---|
Page 510(k) Summary Section 5
5 / 7
| (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat frame & arm rest) | (include seat & arm rest) | (include seat frame & arm rest) | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Turn Radius | 780 mm(31") | 900 mm(35.5") | 780 mm(31") | 910 mm(36") | 875 mm(34.5") | 895 mm(35") | 975 mm (38.5") | 780mm(31") | 875mm(34.5") | |
| Brakes | Dynamic braking and electromagnetic brake | Dynamic braking and electromagnetic brake | Dynamic braking and electromagnetic brake | |||||||
| Motor Output | DC 12V x 180W | 2 x 150W | 2 x 180 W | 2 x 180 W | 2 x 150 W | |||||
| Battery | SLA: 12V-20ahLithium: 12V-20ah | SLA:24V-15ahLithium: 24V-15ah | SLA: 24V-15ahLithium: 24V-15ah | SLA: 24V-15ahLithium: 24V-15ah | SLA: 24V-15ahLithium: 24V-15ah | |||||
| Max Speed | 6.5 kph (4 mph) | 6.5 kph (4 mph) | 6.5 kph (4 mph) | 9.0 kph (5.6 kph) | 9.0 kph (5.6 kph) | 6.5 kph (4 mph) | 6.5 kph (4 mph) | |||
| Climbing angle | 9~12 Degrees | 9 Degrees | 9 Degrees | 9 Degrees | 9 Degrees | 8 Degrees | ||||
| Travel Distance | SLA: 13 km (8 miles)Lithium: 16 km (10 miles) | SLA: 16 km (10 miles)Lithium: 20 km (12.4 miles) | SLA:18 km (11 miles)Lithium: 22 km (13.6 miles) | SLA:15 km (9.3 miles)Lithium: 19 km (11.8 miles) | SLA:14 km (8.5 miles)Lithium: 18 km (11 miles) | SLA:18 km (11 miles)Lithium: 22 km (13.6 miles) |
5-5
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SupnScoot^
5.3 Equivalence comparison to marketed device
Technological characteristics :
The device features and use parameters of the Freerider and HEARTWAY scooters are very similar Both are battery operated and have brake systems. Batteries capacity and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective scooters.
| EUROGREEN International Inc. | HEARTWAY USA. | FREERIDER Corp. | |
|---|---|---|---|
| K number | - | K101143Appendix 9.1 | K110165Appendix 9.2 |
| Indication for Use | As a motorized portableelectric vehicle for indoor oroutside use by persons withmedical conditions requiringassistance. | The device is intendedfor medical purposes toprovide mobility topersons restrictedto a seated position. | The device providestransportation for anelerly or disabledperson. It can be usedin variety of indoorand outdoor settings. |
| Model Type | STD01/ STD02/ SPC01/SPC02/ HD01/ HD02/ SP01/SP02/ MD01/ MD02 | S11 | FR168-3A3 |
| Front wheel size | 200 x 65 mm ( 8 x 2.5")200 x 50mm (8 x 2") | 240 x 75 mm(9.5 x 3" ) | 200 x 50 mm |
| Rear wheel size | 200 x 65 mm ( 8 x 2.5")260 x 85mm (10 x 3") | Option | 200 x 50 mm |
| Ground clearance | 50 mm (2") | 70 mm | 86 mm |
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| SupoScootn |
|---|
| ------------ |
510(k) Summary
| 7 | / | 7 |
|---|---|---|
| --- | --- | --- |
| Length | 945 | 1070 mm (42") | 945 mm |
|---|---|---|---|
| Width | 550 | 580 mm (23") | 508 mm |
| Height | 820mm (32")-930mm (36.6") | 915mm | - |
| Seat height | 560mm (22")- 620mm (24.5") | 400mm | - |
| Max Loading(weight capacity) | 80 | 120 kg (265 lbs) | 110 kg(250 lbs) |
| Weight without seat/battery | 14.9 | 48kgs(105lbs) | - |
| Weight of Seat | 5.8 | - | - |
| Weight w/battery | 27.3 | 58kgs(127.6 lbs) | - |
| Brakes | Dynamic braking andelectromagnetic brake | - | - |
| Turn Radius | 780~975 mm | 1980mm | 820 mm |
| Motor Output | 1 x 180W/ 2 x 150 W/ 2 x 180 W | 400 Watt | - |
| Battery | SLA: 12V-20ah/ 24V-15ahLithium: 12V-20ah/ /24V-15ah | 12V-22ah x 2 pcs | 24V 12ah |
| on/off board batterychargers | Off board battery charger | Off board battery charger | Off board battery charger |
| Max Speed(forward) | 6.5 kph (4 mph)9.0 kph (5.6 kph) | 8 kph (5 mph) | 6.5 kph (4 mph) |
| Travel Distance | SLA: 13 | 20km (13 miles) | 16km (10 miles) |
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| Image: SupaScoota logo | Section 5510(k) Summary | Page8 / 7 | |
|---|---|---|---|
| Climbing angle | 8~12 Degrees | 10° Degrees | - |
| Steering wheels/drive wheels | 200mm (8") / 200mm (8")200mm (8") / 260mm (10") | - /240mmx75mm(9.5"x3") | = |
5.4 Safety and Effectivenes
The substantially equivalence to other commercially products (motorized vehicle) including FREERIDER MODEL LUGGIE MODEL (K110165) and HEART WAY Power Mobility Scooter, S11 (K101143). The comparison table in below table list the primary technical aspects and specifications that are pertinent to motorized three-wheeled vehicle. The "SupaScoota" Motorized is as safe and effective as the predicate devices.
5.5 Non-clinical Testing
"SupaScoota" Motorized vehicle has done the series test to confirmation its safety and effectiveness in pre-clinical test. The tests are conducted with ISO 7176-1 serial standards. All test results are in compliance with it and were similar to predicate device.
- ISO 7176-1 : Static stability test 0
- ISO 7176-2 : Dynamic stability test O
- 0 ISO 7176-3 : Efficiency of brakes tests
- O ISO 7176-4 : Theoretical distance range tests
- ISO 7176-5 : Overall dimensions, Mass, Turning, Diameter tests O
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Sup^Scoot^
510(k) Summary
- 0 ISO 7176-6 : Maximum speed, acceleration and retardation tests
- ISO 7176-7 : Seating and wheel dimension tests O
- 0 ISO 7176-8 : Static, impact and fatigue strengths tests
- O ISO 7176-9 : Climatic tests
- O ISO 7176-10 : Obstacle-climbing ability tests
- ISO 7176-11 : Test dummies 0
- ISO 7176-13 : Determination of coefficient of friction of test surfaces 0
- 0 ISO 7176-14 : Power and control system
- O ISO 7176-15 : Wheelchairs -- Part 15: Requirements for information disclosure, documentation and labelling.
- ISO 7176-21 (EN 12184) : EMC test
5.6 Conclusion
"SupaScoota" Motorized vehicle is a safe, reliable and effective medical device, meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.
§ 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).