SupaScoota Motorized vehicle

K143557 · Eurogreen International, Inc. · INI · Sep 16, 2015 · Physical Medicine

Device Facts

• Record ID: K143557
• Device Name: SupaScoota Motorized vehicle
• Applicant: Eurogreen International, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Sep 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.

Device Story

SupaScoota is a motorized portable electric vehicle designed for indoor and outdoor mobility assistance. Operated by the user via onboard controls, the device uses battery-powered electric motors to drive wheels. It features dynamic and electromagnetic braking systems for speed control and stopping. The device is intended for individuals with medical conditions that restrict mobility. By providing a seated, motorized transport platform, it enables users to navigate various environments, potentially increasing independence and accessibility. The device is available in multiple models (STD, HD, SPC, SP, MD) with varying wheel configurations (3 or 4 wheels), motor outputs, and battery types (SLA or Lithium).

Clinical Evidence

No clinical data. Safety and effectiveness were established through bench testing in accordance with ISO 7176 series standards, including static/dynamic stability, braking efficiency, theoretical distance range, dimensions/turning diameter, speed/acceleration, fatigue strength, climatic testing, obstacle climbing, and EMC testing.

Technological Characteristics

Battery-operated motorized vehicle; 3 or 4-wheel configurations; DC motor output (150W-180W); SLA or Lithium battery options; dynamic and electromagnetic braking; dimensions vary by model. Complies with ISO 7176 series standards for stability, braking, and performance. Standalone operation.

Indications for Use

Indicated for persons with medical conditions requiring assistance who need a motorized portable electric vehicle for indoor or outdoor mobility.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• HEARTWAY Power Mobility Scooter, S11 (K101143)
• FREERIDER Corp. Luggie Model (K110165)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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^ |
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#### 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,<br>Changhua County, Taiwan |
| Phone | [phone] |
| Fax | [phone] |
| Contact Person | David Hsieh |
| Contact Title | President |
| Contact E-mail | [e-mail] |

### 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 |
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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 | 60~65 mm (2.4~2.6") |
| Length | 945~1100 mm (37~43") |
| Width | 550~600 mm (22~26") |
| Height | 820mm (32")-930mm (36.6") |
| Seat height | 560mm (22")- 620mm (24.5") |
| Max Loading (weight capacity) | 80 ~125kg (175~275 lbs) |
| Weight without seat/ battery | 14.9~21.9 kg (33~48.5 lbs) |
| Weight of Seat | 5.8~11.5 kg (13~25 lbs) |
| | (include seat frame & arm rest) |
| Weight w/battery | 27.3~42.6 kg (60~94 lbs) |
| 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: 13~18km (8~11 miles) |

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| Image: SupaScoota logo | Section 5<br>510(k) Summary | Page<br>3 / 7 |
|-----------------------------------|-----------------------------------------------------|---------------|
| Lithium: 16~22 km (10~13.6 miles) | | |
| Climbing angle | 8~12 Degrees | |
| Steering wheels/drive wheels | 200mm (8") / 200mm (8")<br>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 +2<br>stabilizer<br>wheels | 4 wheels | 3 wheels+2<br>stabilizer<br>wheels | 4 wheels | 4 wheels | 4 wheels | 4 wheels | 4 wheels | 3 wheels+2<br>stabilizer<br>wheels | 4 wheels |
| Front wheel size | 200 x 65 mm<br>(8x2.5") | 200 x 50 mm<br>(8x2") | 200 x 65 mm<br>(8x2.5") | 200 x 50 mm<br>(8x2") | 200 x 65 mm<br>(8x2.5") | 200 x 50 mm<br>(8x2") | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") | 200 x 50 mm<br>(8x2") |
| Rear wheel size | 200 x 65 mm<br>(8x2.5") | 200 x 65 mm<br>(8x2.5") | 200 x 65 mm<br>(8x2.5") | 200 x 65 mm<br>(8x2.5") | 200 x 65 mm<br>(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<br>(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<br>(37") | 1000 mm<br>(39") | 970 mm<br>(38") | 1010 mm<br>(40") | 1000 mm<br>(39") | 1040 mm<br>(41") | 1100 mm (43") | 600 mm (24") | 945mm<br>(37") | 1000mm<br>(39") |
| Width | 550 mm<br>(22") | 550 mm<br>(22") | 570 mm<br>(22.5") | 570 mm<br>(22.5") | 570 mm<br>(22.5") | 600 mm<br>(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<br>(34.5 lbs) | 14.9 kgs (33 lbs) | 20.3 (44.5 lbs) | 19.8 kgs<br>(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)<br>(include seat frame & | 5.8 kgs (13 lbs)<br>(include seat frame & | 8.6 kgs (19 lbs) | 11.5 kgs (25 lbs) | 5.8kg (13 lbs included<br>seat frame) | 5.8kg (13 lbs included<br>seat frame) |

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Page 510(k) Summary Section 5

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| | (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<br>(31") | 900 mm<br>(35.5") | 780 mm<br>(31") | 910 mm<br>(36") | 875 mm<br>(34.5") | 895 mm<br>(35") | 975 mm (38.5") | 780mm<br>(31") | 875mm<br>(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-20ah<br>Lithium: 12V-20ah | | | SLA:24V-15ah<br>Lithium: 24V-15ah | SLA: 24V-15ah<br>Lithium: 24V-15ah | | SLA: 24V-15ah<br>Lithium: 24V-15ah | SLA: 24V-15ah<br>Lithium: 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)<br>Lithium: 16 km (10 miles) | | | SLA: 16 km (10 miles)<br>Lithium: 20 km (12.4 miles) | SLA:18 km (11 miles)<br>Lithium: 22 km (13.6 miles) | | SLA:15 km (9.3 miles)<br>Lithium: 19 km (11.8 miles) | SLA:14 km (8.5 miles)<br>Lithium: 18 km (11 miles) | SLA:18 km (11 miles)<br>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 | - | K101143<br>Appendix 9.1 | K110165<br>Appendix 9.2 |
| Indication for Use | As a motorized portable<br>electric vehicle for indoor or<br>outside use by persons with<br>medical conditions requiring<br>assistance. | The device is intended<br>for medical purposes to<br>provide mobility to<br>persons restricted<br>to a seated position. | The device provides<br>transportation for an<br>elerly or disabled<br>person. It can be used<br>in variety of indoor<br>and outdoor settings. |
| Model Type | STD01/ STD02/ SPC01/<br>SPC02/ HD01/ HD02/ SP01/<br>SP02/ MD01/ MD02 | S11 | FR168-3A3 |
| Front wheel size | 200 x 65 mm ( 8 x 2.5")<br>200 x 50mm (8 x 2") | 240 x 75 mm<br>(9.5 x 3" ) | 200 x 50 mm |
| Rear wheel size | 200 x 65 mm ( 8 x 2.5")<br>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 |
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#### 510(k) Summary

| 7 | / | 7 |
|---|---|---|
|---|---|---|

| Length | 945~1100 mm (37~43") | 1070 mm (42") | 945 mm |
|----------------------------------|-----------------------------------------------------------------|---------------------------|---------------------------|
| Width | 550~600 mm (22~26") | 580 mm (23") | 508 mm |
| Height | 820mm (32")-930mm (36.6") | 915mm | - |
| Seat height | 560mm (22")- 620mm (24.5") | 400mm | - |
| Max Loading<br>(weight capacity) | 80~125kg (175~275 lbs) | 120 kg (265 lbs) | 110 kg(250 lbs) |
| Weight without seat/battery | 14.9~21.9 kg (33~48.5 lbs) | 48kgs(105lbs) | - |
| Weight of Seat | 5.8~11.5 kg (13~25 lbs)<br>(include seat frame & arm rest) | - | - |
| Weight w/battery | 27.3~42.6 kg<br>(60~94 lbs) | 58kgs(127.6 lbs) | - |
| Brakes | Dynamic braking and<br>electromagnetic 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-15ah<br>Lithium: 12V-20ah/ /<br>24V-15ah | 12V-22ah x 2 pcs | 24V 12ah |
| on/off board battery<br>chargers | Off board battery charger | Off board battery charger | Off board battery charger |
| Max Speed<br>(forward) | 6.5 kph (4 mph)<br>9.0 kph (5.6 kph) | 8 kph (5 mph) | 6.5 kph (4 mph) |
| Travel Distance | SLA: 13~18 km (8~11 miles)<br>Lithium: 16~22 km (10~13.6 miles) | 20km (13 miles) | 16km (10 miles) |

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| Image: SupaScoota logo | | Section 5<br>510(k) Summary | Page<br>8 / 7 |
|------------------------------|-----------------------------------------------------|-----------------------------|---------------|
| Climbing angle | 8~12 Degrees | 10° Degrees | - |
| Steering wheels/drive wheels | 200mm (8") / 200mm (8")<br>200mm (8") / 260mm (10") | - /<br>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.