K Number
K143557
Device Name
SupaScoota Motorized vehicle
Date Cleared
2015-09-16

(275 days)

Product Code
Regulation Number
890.3800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
Device Description
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.
More Information

No
The device description and performance studies focus on the mechanical and electrical aspects of a mobility scooter, with no mention of AI or ML technologies.

No
This device is a mobility aid for individuals with medical conditions requiring assistance and does not provide therapy for those conditions.

No

Explanation: The device is described as a "motorized portable electric vehicle" for "persons with medical conditions requiring assistance," which are generally known as mobility scooters or power wheelchairs. Its intended use and the performance studies listed (e.g., stability, braking, speed, obstacle-climbing) focus on its mechanical and operational characteristics for transportation, not on diagnosing or detecting medical conditions. There is no mention of image processing, AI/ML, or any functionality related to analyzing biological data or presenting diagnostic information.

No

The device description clearly outlines a physical, motorized vehicle with hardware components like wheels, brakes, batteries, and a charger. The performance studies also focus on physical characteristics and safety of the hardware.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
  • Device Description and Intended Use: The description clearly states this is a "motorized portable electric vehicle" for assisting people with medical conditions. It's a mobility aid, not a device that analyzes biological samples.
  • Lack of IVD Characteristics: The description doesn't mention any components or functions related to sample collection, analysis, reagents, or laboratory testing.
  • Performance Studies: The performance studies listed are related to the physical and mechanical aspects of a mobility device (stability, braking, speed, strength, etc.), not diagnostic accuracy or analytical performance.

This device falls under the category of a mobility aid or assistive device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes

INI

Device Description

Intended Use : As a motorized portable electric vehicle for indoor or

outside use by persons with medical conditions requiring assistance.

ItemDescription
Common NameMotorized vehicle
Trade Name"SupaScoota" Motorized vehicle
Classification NameMotorized vehicle
Regulation Number890.3800
Product CodeINI
Device ClassClass 2
ModelSTD01/ STD02/ HD01/ HD02/ SPC01/ SPC02/
SP01/ SP02/ MD01/ MD02
Number of wheels3 wheels+2 stabilizer wheels
4 wheels
Front wheel size200 x 65 mm (8 x 2.5")
200 x 50mm (8 x 2")
Rear wheel size200 x 65 mm (8 x 2.5")
260 x 85mm (10 x 3")
Ground clearance6065 mm (2.42.6")
Length9451100 mm (3743")
Width550600 mm (2226")
Height820mm (32")-930mm (36.6")
Seat height560mm (22")- 620mm (24.5")
Max Loading (weight capacity)80 125kg (175275 lbs)
Weight without seat/ battery14.921.9 kg (3348.5 lbs)
Weight of Seat5.811.5 kg (1325 lbs)
(include seat frame & arm rest)
Weight w/battery27.342.6 kg (6094 lbs)
BrakesDynamic braking and electromagnetic brake
Turn Radius780~975 mm
Motor Output1 x 180W/ 2 x 150 W/ 2 x 180 W
BatterySLA: 12V-20ah/ 24V-15ah
Lithium: 12V-20ah/ / 24V-15ah
On/off board battery chargersOff board battery charger
Max Speed6.5 kph (4 mph)/ 9.0 kph (5.6 mph)
Travel DistanceSLA: 1318km (811 miles)
Lithium: 1622 km (1013.6 miles)
Climbing angle8~12 Degrees
Steering wheels/drive wheels200mm (8") / 200mm (8")
200mm (8") / 260mm (10")

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

"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
  • 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

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

Not Found

Predicate Device(s)

K110165, K101143

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

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

SupnScoot^
------------

Date of preparation : Aug. 07, 2015

5.1 Applicant Information

Type of SubmissionOriginal Application- Traditional 510(k)
Applicant NameEUROGREEN INTERNATIONAL INC.
AddressNo.48, Ln. 220, Sec. 1, Fuzun Rd., Yuanlin Township,
Changhua County, Taiwan
Phone+886-4-8319633
Fax+886-4-8332226
Contact PersonDavid Hsieh
Contact TitlePresident
Contact E-mailsales@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.

ItemDescription
Common NameMotorized vehicle
Trade Name"SupaScoota" Motorized vehicle
Classification NameMotorized vehicle
Regulation Number890.3800
Product CodeINI
Device ClassClass 2
ModelSTD01/ STD02/ HD01/ HD02/ SPC01/ SPC02/
SP01/ SP02/ MD01/ MD02

4

SupnScootn
------------

510(k) Summary

Number of wheels3 wheels+2 stabilizer wheels
4 wheels
Front wheel size200 x 65 mm (8 x 2.5")
200 x 50mm (8 x 2")
Rear wheel size200 x 65 mm (8 x 2.5")
260 x 85mm (10 x 3")
Ground clearance6065 mm (2.42.6")
Length9451100 mm (3743")
Width550600 mm (2226")
Height820mm (32")-930mm (36.6")
Seat height560mm (22")- 620mm (24.5")
Max Loading (weight capacity)80 125kg (175275 lbs)
Weight without seat/ battery14.921.9 kg (3348.5 lbs)
Weight of Seat5.811.5 kg (1325 lbs)
(include seat frame & arm rest)
Weight w/battery27.342.6 kg (6094 lbs)
BrakesDynamic braking and electromagnetic brake
Turn Radius780~975 mm
Motor Output1 x 180W/ 2 x 150 W/ 2 x 180 W
BatterySLA: 12V-20ah/ 24V-15ah
Lithium: 12V-20ah/ / 24V-15ah
On/off board battery chargersOff board battery charger
Max Speed6.5 kph (4 mph)/ 9.0 kph (5.6 mph)
Travel DistanceSLA: 1318km (811 miles)

5

| Image: SupaScoota logo | Section 5
510(k) Summary | Page
3 / 7 |
|-----------------------------------|-----------------------------------------------------|---------------|
| Lithium: 1622 km (1013.6 miles) | | |
| Climbing angle | 8~12 Degrees | |
| Steering wheels/drive wheels | 200mm (8") / 200mm (8")
200mm (8") / 260mm (10") | |

6

4 / 7 Page 510(k) Summary Section 5

StandardHeavy DutySuperior DutySportMD
STD01STD02HD01HD02SPC01SPC02SP01SP02MD01MD02
Number of wheels3 wheels +2
stabilizer
wheels4 wheels3 wheels+2
stabilizer
wheels4 wheels4 wheels4 wheels4 wheels4 wheels3 wheels+2
stabilizer
wheels4 wheels
Front wheel size200 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 size200 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 clearance60 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")
Length945 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")
Width550 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 Loading80 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 seat15.6 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 Seat5.8 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 included
seat frame)5.8kg (13 lbs included
seat frame)

5-4

7

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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 Radius780 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")
BrakesDynamic braking and electromagnetic brakeDynamic braking and electromagnetic brakeDynamic braking and electromagnetic brake
Motor OutputDC 12V x 180W2 x 150W2 x 180 W2 x 180 W2 x 150 W
BatterySLA: 12V-20ah
Lithium: 12V-20ahSLA:24V-15ah
Lithium: 24V-15ahSLA: 24V-15ah
Lithium: 24V-15ahSLA: 24V-15ah
Lithium: 24V-15ahSLA: 24V-15ah
Lithium: 24V-15ah
Max Speed6.5 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 angle9~12 Degrees9 Degrees9 Degrees9 Degrees9 Degrees8 Degrees
Travel DistanceSLA: 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

8

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
Appendix 9.1K110165
Appendix 9.2
Indication for UseAs a motorized portable
electric vehicle for indoor or
outside use by persons with
medical conditions requiring
assistance.The device is intended
for medical purposes to
provide mobility to
persons restricted
to a seated position.The device provides
transportation for an
elerly or disabled
person. It can be used
in variety of indoor
and outdoor settings.
Model TypeSTD01/ STD02/ SPC01/
SPC02/ HD01/ HD02/ SP01/
SP02/ MD01/ MD02S11FR168-3A3
Front wheel size200 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 size200 x 65 mm ( 8 x 2.5")
260 x 85mm (10 x 3")Option200 x 50 mm
Ground clearance50 mm (2")70 mm86 mm

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510(k) Summary

7/7
---------
Length9451100 mm (3743")1070 mm (42")945 mm
Width550600 mm (2226")580 mm (23")508 mm
Height820mm (32")-930mm (36.6")915mm-
Seat height560mm (22")- 620mm (24.5")400mm-
Max Loading
(weight capacity)80125kg (175275 lbs)120 kg (265 lbs)110 kg(250 lbs)
Weight without seat/battery14.921.9 kg (3348.5 lbs)48kgs(105lbs)-
Weight of Seat5.811.5 kg (1325 lbs)
(include seat frame & arm rest)--
Weight w/battery27.3~42.6 kg
(60~94 lbs)58kgs(127.6 lbs)-
BrakesDynamic braking and
electromagnetic brake--
Turn Radius780~975 mm1980mm820 mm
Motor Output1 x 180W/ 2 x 150 W/ 2 x 180 W400 Watt-
BatterySLA: 12V-20ah/ 24V-15ah
Lithium: 12V-20ah/ /
24V-15ah12V-22ah x 2 pcs24V 12ah
on/off board battery
chargersOff board battery chargerOff board battery chargerOff 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 DistanceSLA: 1318 km (811 miles)
Lithium: 1622 km (1013.6 miles)20km (13 miles)16km (10 miles)

10

| Image: SupaScoota logo | | Section 5
510(k) Summary | Page
8 / 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

11

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.