(360 days)
Not Found
No
The description focuses on mechanical and electrical components and standard control mechanisms (throttle, electronic controller, magnetic motor brake). There is no mention of AI, ML, or any learning or adaptive capabilities.
No
The device is a mobility aid for individuals with medical conditions requiring assistance, but it does not directly treat or diagnose a medical condition.
No
The device is described as a "motorized portable electric vehicle" for mobility assistance, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, battery-operated motorized vehicle with a steel frame, battery, charger, throttle, and braking system. This is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance." This describes a mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical vehicle for transportation, not a device that analyzes 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 processes typically associated with in vitro diagnostics.
- Predicate Device: The predicate device is also a "Motorized vehicle," further confirming its classification as a mobility device.
Based on the provided information, this device clearly falls under the category of a mobility aid or personal transport 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 (comma separated list FDA assigned to the subject device)
INI
Device Description
A battery operated lightweight portable mobility device designed for personal travel indoors and limited outdoor use and available in 4 wheel configurations. It is used in a sitting position and operated by a hand controlled throttle located on the handle bars. Braking is automatically controlled when releasing the throttle by the electronic controller and magnetic motor brake. The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport. Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.
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)
Non-clinical Testing: "SupaScoota" Motorized vehicle has done the series test to confirm its safety and effectiveness in pre-clinical test. The tests are conducted with ISO 7176 serial standards. All test results are in compliance with it and were similar to predicate device.
Tests conducted:
- ISO 7176-1 : Static stability test
- ISO 7176-2 : Dynamic stability test
- ISO 7176-3 : Efficiency of brakes tests
- ISO 7176-4 : Theoretical distance range tests
- ISO 7176-5 : Overall dimensions, Mass, Turning, Diameter tests
- ISO 7176-6 : Maximum speed, acceleration and retardation tests
- ISO 7176-7 : Seating and wheel dimension tests
- ISO 7176-8 : Static, impact and fatigue strengths tests
- ISO 7176-9 : Climatic tests
- ISO 7176-10 : Obstacle-climbing ability tests
- ISO 7176-11 : Test dummies
- ISO 7176-13 : Determination of coefficient of friction of test surfaces
- ISO 7176-14 : Power and control system
- ISO 7176-15 : Information disclosure, documentation and labeling
- ISO 7176-16 : Resistance to ignition of postural support devices
- ISO 7176-21 (EN 12184) : EMC test
- ISO 7176-25 : Batteries and chargers for powered wheelchairs
- IEC 62133 : Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin delayed-type hypersensitivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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 & 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.
September 19, 2019
Eurogreen International Inc. David Hsieh General Manager No. 48, Lane 220, Sec. 1, Fu-Zun Rd., Yuan-Lin Township Chang-Hua County, 51055 Taiwan
Re: K182631
Trade/Device Name: "SupaScoota" Motorized vehicle - Spartan (Sumo) / Spartan SP (Sumo SP) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 20, 2019 Received: August 20, 2019
Dear David 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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182631
Device Name
"SupaScoota" Motorized Vehicle : Spartan(Sumo), Spartan SP(Sumo SP)
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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3
| Image: SupaScoota Logo | K182631 | Page |
|---|---|---|
| 510(k) Summary | 1/8 |
1 Submitter:
| Company Name: | Eurogreen International Inc. |
|---|---|
| Company Address: | No.48, Ln.220, Sec.1, Fuzun Rd., Yuanlin Township, |
| Changhua County, 51055, Taiwan | |
| Telephone: | +886-4-8319633 |
| Fax: | +886-4-8332226 |
| Contact person: | David Hsieh |
| Summary Preparation Date: | September 17, 2019 |
2 Device Name:
| Trade Name: | "SupaScoota” Motorized vehicle, Spartan(Sumo)/ Spartan
SP(Sumo SP) |
|----------------------|-----------------------------------------------------------------------|
| Classification Name: | Motorized three-wheeled vehicle |
| Regulation Number: | 890.3800 |
| Product Code: | INI |
| Device Class: | Class 2 |
| Panel: | Physical Medicine |
3 Predicate Device:
K143557, Eurogreen International Inc., "SupaScoota" Motorized vehicle SP-01
4 Indications for Use:
"SupaScoota" Motorized vehicle, Spartan(Sumo)/ Spartan SP(Sumo SP), as a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
5 Device Description:
A battery operated lightweight portable mobility device designed for personal travel indoors and limited outdoor use and available in 4 wheel configurations. It is used in a sitting position and operated by a hand controlled throttle located on the handle bars. Braking is automatically controlled when releasing the throttle by the electronic controller and magnetic motor brake.
4
| Image: SupaScoota logo | K182631 | Page |
|---|---|---|
| 510(k) Summary | 2 / 8 |
The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport.
Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.
| Specification | Spartan(Sumo) | Spartan SP(Sumo SP) |
|---|---|---|
| Photograph | Image: Spartan(Sumo) | Image: Spartan SP(Sumo SP) |
| Number of wheels | 4 wheels | 4 wheels |
| Front wheel size | 200 x 65 mm (8x2.5") | 200 x 65 mm (8x2.5") |
| Rear wheel size | 200 x 65 mm (8x2.5") | 260 x 85mm (10 x 3") |
| Ground clearance | 65 mm (2.6") | 65 mm (2.6") |
| Length | 1100 mm (43.7") | 1130 mm (44.5") |
| Width | 630 mm (24.8") | 660 mm (26") |
| Weight of front frame | ||
| (without seat) | 13.5 kgs (29.7 lbs) | 13.5 kgs (29.7 lbs) |
| Weight of front frame | ||
| (without seat and front | ||
| wheels) | 11.3 kgs (25 lbs) | 11.3 kgs (25 lbs) |
| Weight of back frame | ||
| (without seat) | 12.2 kgs (27 lbs) | 13.4 kgs (29.5 lbs) |
| Weight of Seat (include seat | ||
| frame & arm rest) | 10.6 kgs (23.3 lbs) | 10.6 kgs (23.3 lbs) |
| Max Loading (on level | ||
| ground) | 200 kgs (440 lbs) | 200 kgs (440 lbs) |
| Turn Radius | 1000 mm (39.4") | 1000 mm (39.4") |
| Motor Output | 2 x 180 W | 2 x 180 W |
| Transmission | Worm Drive Gearbox | Worm Drive Gearbox |
5
| Sup^Scoot^ | |
|---|---|
| ------------ | -- |
510(k) Summary
| Reverse | Forward/Reverse Switch |
|---|---|
| Brakes | Dynamic Braking and Electromagnetic Brake |
| Battery-SLA | 24V-15ah / 9.2kg (20 lbs) |
| Battery-Lithium (optional) | 24V-15ah / 4.0kg (9 lbs) or 24V-12ah / 3.3kg (7.3 lbs) |
| Charger-SLA battery | Off board 24 volt 2 amp |
| Charger-Lithium battery | Off board 24 volt 4 amp |
| Max Speed | 6.2 kph (3.9 mph) 8.2 kph (5 mph) |
| 2nd speed choice | 4.2 kph (2.6 mph) 5.5 kph (3.4 mph) |
| Slope Grade Ability | 150 kg-8 degree, 175 kg-6 degree 150 kg-7 degree, 175 kg-4 degree |
| Travel Distance (with standard SLA battery) | Up to 10 km (6.2 miles) |
| Travel Distance | |
| -with 15ah Lithium battery | |
| -with 12ah Lithium battery | Up to 13 km (8 miles) |
| Up to 11 km (6.8 miles) | |
| Arm Rests | Distance between armrests 45-57cm (18-22.4") |
| Brake distance-Normal operation | |
| (Horizontal-Forward-Max speed) | 1.0-1.5 m/s 1.0-1.5 m/s |
| Time to brake (1~1.5M) | 06 |
| Operating surface & environment | Use it on firm, even surfaces. Such as concrete, asphalt and indoor flooring; not operate it in sand, loose soil or over rough terrain. |
| Frame material | Steel |
6 Technological characteristics:
Unique one piece folding frame available in several models to suit different users and applications. The compact design and minimal component weight are of significant benefit to the elderly who are independent and have a need to transport the scooter in their motor vehicle. The electronically controlled speed reduction system which operates when turning is a valuable safety features for elderly users.
It's a rear wheel drive scooter with four wheels, weight capacity 200kgs, average travel distance with 24V15ah Sealed Lead Acid battery is 10 km, with Lithium
6
| Image: SupaScoota logo | K182631 | Page |
|---|---|---|
| 510(k) Summary | 4 / 8 |
batteries 24V15ah is 13km, 24V12ah is 11km, the maximum speed is 6.2kph for Spartan(Sumo), 8.2kph for Spartan SP (Sumo SP)
7 Substantial Equivalence comparison:
The "SupaScoota" Motorized vehicle, Spartan(Sumo)/ Spartan SP(Sumo SP) and the "SupaScoota" Motorized vehicle SP-01 (K143557) have the same design, intended use, classification name and product code.
Per the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], we choose Eurogreen International Inc., our own devices, to be our predicate device. The reasons are Eurogreen International Inc. had 510(k) already, same intended use and technological characteristics to the new subject devices.
The device features and use parameters of the Eurogreen International Inc. "SupaScoota" Motorized Vehicle model SP01 (K143557) are the same. Both are battery operated and have brake systems. Batteries capacity and battery chargers are the same and are provided with the scooters.
7
Image /page/7/Picture/0 description: The image shows the word "SupnScoot" in a stylized font. The letters are black and bold. The letters "n" and "t" are stylized with a caret symbol above them.
510(k) Summary
| | EUROGREEN
International Inc. | EUROGREEN
International Inc. | Differences |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | | |
| K number | K182631 | K143557 | - |
| Identification | Subject devices | Predicate device | |
| Indication for Use | As a motorized portable
electric vehicle for indoor
or outside use by persons
with medical conditions
requiring assistance. | As a motorized portable
electric vehicle for indoor
or outside use by persons
with medical conditions
requiring assistance. | Same |
| Model Type | Spartan(Sumo)
Spartan SP(Sumo SP) | "SupaScoota" Motorized
Vehicle-SP01 | - |
| Front wheel size | 200 x 65mm (8 x 2.5") | 200 x 65mm (8 x 2.5") | Same |
| Rear wheel size | Spartan(Sumo):
200 x 65mm (8 x 2.5")
Spartan SP(Sumo SP):
260 x 85mm (10 x 3") | 260 x 85mm (10 x 3") | It does not affect
the safety and
performance.
(Ref. Appendix
7.37.4) |1130mm
| Ground clearance | 65mm (2.6") | 65mm (2.6") | Same |
| Length | 1110
(43.744.5") | 1100mm (43") | It does not affect660mm (24.8
the safety and
performance. |
| Width | 63026") | 600mm (26") | It does not affect13.4kg (27~29.5 lbs) | 11.4kg (25 lbs) | It does not affect
the safety and
performance. |
| Weight of front
frame (without seat) | 13.5kg (29.7 lbs) | 10.9kg (24 lbs) | It does not affect
the safety and
performance. |
| Weight of front
frame (without seat
& front wheels) | 11.3kg (25 lbs) | 8.7kg (19 lbs) | It does not affect
the safety and
performance. |
| Weight of back
frame (without seat) | 12.2
the safety and
performance. |
| Weight of Seat
(include seat frame
& arm rest) | 10.6kg (23.3 lbs) | 8.6kg (19 lbs) | It does not affect
the safety and
performance |
8
| SupnScootn | |
|---|---|
| -- | ------------ |
510(k) Summary
| Max Loading(on
level ground) | 200kg (440 lbs) | 125kg (275 lbs) | These are options
according the
customer needs. All
models have pass
the loading test.
(Ref. Appendix
7.37.4) |8.2kph (3.9
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Turn Radius | 1000mm (39.4") | 975mm (38.5") | - |
| Motor Output | 2 x 180 W | 2 x 180 W | Same |
| Transmission | Worm Drive Gearbox | Worm Drive Gearbox | Same |
| Reverse | Forward/Reverse Switch | Forward/Reverse Switch | Same |
| Brakes | Dynamic braking and
electromagnetic brake | Dynamic braking and
electromagnetic brake | Same |
| Battery | SLA:
24V-15ah/9.2kg (20 lbs)
Lithium (Optional) :
24V-15ah/4kg (9 lbs) or
24V-12ah/3.3kg (7.3 lbs) | SLA:
24V-15ah/9.2kg (20 lbs)
Lithium (Optional) :
24V-15ah/4kg (9 lbs) | Same |
| Charger | SLA:
Off board 24 volt 2 amp
Lithium:
Off board 24 volt 4 amp | SLA:
Off board 24 volt 2 amp
Lithium:
Off board 24 volt 4 amp | Same |
| Max Speed | 6.25mph) | 9kph (5.6mph) | - |5.5kph (2.6~3.4mph) | 6kph (3.7mph) | - |
| 2nd speed choice | 4.2
| Slope Grade Ability | Spartan(Sumo):
150kg: 8 degree
175kg: 6 degree
Spartan SP(Sumo SP):
150kg: 7 degree
175kg: 4 degree | 9 degree (Max.) | It does not affect
the safety and
performance. |
| Travel Distance | SLA:
Up to 10km (6.2 miles)
Lithium-24V15ah:
Up to 13km (8 miles)
Lithium-24V12ah:
Up to 11km (6.8miles) | SLA:
Up to 14km (8.5miles)
Lithium:
Up to 18km (11miles) | - |
9
| SUONSCOOLA | |
|---|---|
| ------------ | -- |
510(k) Summary
| Arm Rests (Distance
| between armrests) | 45 | 45 | - |
|---|---|---|---|
| Speed Reduction | |||
| System | Reduces operating speed | ||
| to a safe level when | |||
| turning | Reduces operating speed | ||
| to a safe level when turning | Same | ||
| Brake | |||
| distance-Normal | |||
| operation (Horizontal- | |||
| Forward-Max speed) | 1.0~1.5 m/s | 1.0-1.5 m/s | Same |
| Controller | Eurogreen SF-1307-24V | Eurogreen SF-1306-24V | Same |
| Time to brake | |||
| (1~1.5M) | 0.6~0.9 seconds | 0.8~0.9 seconds | - |
| Operating surface & | |||
| environment | Use it on firm, even surfaces. | ||
| Such as concrete, asphalt | |||
| and indoor flooring; not | |||
| operate it in sand, loose soil | |||
| or over rough terrain. | Use it on firm, even surfaces. | ||
| Such as concrete, asphalt | |||
| and indoor flooring; not | |||
| operate it in sand, loose soil | |||
| or over rough terrain. | Same | ||
| Frame material | Steel | Steel | Same |
8 Safety and Effectiveness:
The substantially equivalence to Eurogreen International Inc "SupaScoota" Motorized Vehicle model SP01 (K143557). The comparison table above list the primary technical aspects and specifications that are pertinent to motorized four-wheeled vehicle. The "SupaScoota" Motorized vehicle is as safe and effective as the predicate devices.
9 Non-clinical Testing
"SupaScoota" Motorized vehicle has done the series test to confirm its safety and effectiveness in pre-clinical test. The tests are conducted with ISO 7176 serial standards. All test results are in compliance with it and were similar to predicate device.
- ISO 7176-1 : Static stability test
10
| SupnScootn | K182631 | Page |
|---|---|---|
| 510(k) Summary | 8 / 8 |
- ISO 7176-2 : Dynamic stability test O
- ISO 7176-3 : Efficiency of brakes tests ●
- ISO 7176-4 : Theoretical distance range tests
- ISO 7176-5 : Overall dimensions, Mass, Turning, Diameter tests
- O ISO 7176-6 : Maximum speed, acceleration and retardation tests
- ISO 7176-7 : Seating and wheel dimension tests
- ISO 7176-8 : Static, impact and fatigue strengths tests O
- ISO 7176-9 : Climatic tests
- O ISO 7176-10 : Obstacle-climbing ability tests
- O ISO 7176-11 : Test dummies
- ISO 7176-13 : Determination of coefficient of friction of test surfaces
- O ISO 7176-14 : Power and control system
- ISO 7176-15 : Information disclosure, documentation and labeling
- O ISO 7176-16 : Resistance to ignition of postural support devices
- O ISO 7176-21 (EN 12184) : EMC test
- ISO 7176-25 : Batteries and chargers for powered wheelchairs
- O IEC 62133 : Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- O ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin delayed-type hypersensitivity
10 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.