(186 days)
The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
The EQ 20C scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
This 510(k) submission is for a mobility scooter, which is a medical device. The information provided heavily relies on a comparison to a predicate device rather than a comprehensive study with acceptance criteria in the way one might analyze a diagnostic or AI device. Therefore, many of the requested fields are not directly applicable or cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a motorized three-wheeled vehicle), "acceptance criteria" are generally established through adherence to recognized national and international standards for safety and performance, and demonstrating substantial equivalence to a legally marketed predicate device. The performance is then related to how the device meets these standards and compares to the predicate.
| Acceptance Criteria (based on standards & predicate comparison) | Reported Device Performance (KYMCO EQ 20C scooter) |
|---|---|
| Intended Use: Provide mobility to a disabled or elderly person limited to a seated position. | Same as predicate (EQ 30) |
| Compliance with ANSI/RESNA WC Vol. 1 Sec. 7 & 8 | Complied with requirements |
| Compliance with ANSI/RESNA WC Vol. 2 Sec. 21 | Complied with requirements |
| Compliance with ISO 7176 series (e.g., -1, -2, -3, etc.) | Complied with requirements |
| Compliance with ISO 10993 series (e.g., -1, -5, -10) | Complied with requirements (Biocompatibility) |
| Compliance with ISO 14971 | Complied with requirements (Risk Management) |
| Compliance with EN 61000-4 series (e.g., -2, -3, -8) & CISPR 11 | Complied with requirements (EMC) |
| Substantial Equivalence to Predicate Device (KYMCO EQ 30 - K072630) for: | |
| - Maximum load capacity | 127 kg (280 lbs) (Predicate: 150 kg / 330 lbs) - Lower but acceptable difference |
| - Overall dimensions (Height, Length, Width) | 921 mm (36.3"), 1080 mm (43.5"), 520 mm (20.5") (Predicate: 1250 mm, 1240 mm, 560 mm) - Differences noted but not deemed to alter intended use |
| - Seat dimensions (Height, Width, Depth) | 550 mm (21.7"), 427 mm (16.8"), 350 mm (13.8") (Predicate: 756 mm, 455 mm, 400 mm) - Differences noted but not deemed to alter intended use |
| - Motor Rated power | 250 W (Predicate: 350 W) - Lower but not deemed to alter intended use |
| - Braking distance | Forward: 1.0 m (39.4") at max speed (Predicate: 1.24 m / 48.8") - Better braking distance reported |
| - Net weight with battery | 55.5 kg (122 lbs) (Predicate: 84.4 kg / 185.7 lbs) - Lighter |
| - Slope grade ability | 8 degree (Predicate: 10 degree) - Lower but not deemed to alter intended use |
| - Per-charge distance | Up to 21 km (13 miles) (Predicate: Up to 37 km / 23.1 miles) - Lower but not deemed to alter intended use |
| - Maximum speed | Up to 6.5 km/h (4.1 mph), variable (Predicate: Up to 8 km/hr / 4.7 mph), variable) - Lower but not deemed to alter intended use |
| - Turning Radius | 1200 mm (47.2") (Predicate: 1565 mm / 61.6") - Smaller turning radius (better) |
| - Maximum curb height | 50 mm (2") (Predicate: 80 mm / 3.14") - Lower but not deemed to alter intended use |
| - Other features (Lights, Horn, Anti-tip wheels, Operation mode, Armrest) | Similar functions, some stylistic differences or presence/absence of certain features (e.g., headrest, suspension) - Differences noted but not deemed to alter intended use |
Note: The "acceptance criteria" here are implicitly whether the device meets the safety and performance requirements of the cited standards and whether any differences from the predicate device are determined by the FDA to not raise new questions of safety or effectiveness, thus maintaining substantial equivalence. The document doesn't explicitly state quantitative thresholds for each parameter as "acceptance criteria," but rather demonstrates compliance with standards and compares specifications to the predicate.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this submission. The "test" here refers to compliance with international standards and a comparison of specifications with a predicate device. There is no "test set" of patient data or algorithm performance data as would be used for AI/diagnostics.
- Data Provenance: The data comes from the manufacturer's own testing against the listed standards and their internal comparison of the EQ 20C with their predicate device, the EQ 30. No external patient data or clinical trial data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in this context. The "truth" is established by adherence to engineering and safety standards and the direct measurement of device specifications.
4. Adjudication method for the test set
- Not applicable. There is no adjudication method described. Compliance with standards typically involves testing by qualified personnel (either internal or third-party labs) and documenting results against standard requirements.
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 a physical mobility device, not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. Refer to point 5.
7. The type of ground truth used
- The "ground truth" in this context is the established engineering and safety standards (e.g., ANSI/RESNA, ISO, EN, CISPR) and the specifications of the legally marketed predicate device (KYMCO EQ 30). Device performance is evaluated against these standards and compared to the predicate to establish substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. Refer to point 8.
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K1BO940
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Applicant
Name: KWANG YANG MOTOR CO., LTD.
Address: No. 35, Wan Hsing Street, San Min Dist., 803, Kaohsiung, Taiwan
Registration number: 3003851898
Contact person: Yen, Wen Hsi
Phone: +886-7-3822526
Fax: +886-7-3825834
e-mail: yen@mail.kymco.com
Date prepared: Aug. 15, 2013
Device
Trade name: KYMCO
Model: EQ 20C scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: INI
Classification: Class II
Predicate devices
Trade name: KYMCO
Model: EQ 30
510(k) number: K072630
Manufacture: KWANG YANG MOTOR CO., LTD.
Regulation number: 890.3800
Product Code: INI
Classification: Class II
Intend use of device
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device description:
The EQ 20C scooter consists of an un-foldable platform which connects the two front
OCT 07 2013
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wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set.
The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
Summary of non-clinical testing
The EQ 20C scooter complied with the requirements of ANSI/RESNA WC Vol. 1 Sec. 7 and Sec 8, ANSI/RESNA WC Vol. 2 Sec. 21, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8, and CISPR 11.
Statement of substantial equivalence
The EQ 20C scooter is substantially equivalent to the EQ 30 (K072630). They have same intended use of a motor driven, indoor and outdoor transportation vehicle to provide mobility to a disabled or elderly person limited to a seated position.
The design and technological characteristics of this device is basically similar to the predicate device chosen. Both are un-foldable scooters and have the same user interface. While there are minor differences between the devices, do not alter the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.
Conclusion
In accordance with the Federal Food, Drug and Cosmelic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, KWANG YANG MOTOR CO., LTD. concludes that, EQ 20C scooter is substantially equivalent to predicate devices as described herein.
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| The substantial equivalence comparison of the EQ 20C and EQ 30 (K072630) | ||
|---|---|---|
| EQ 20C | EQ30 (K072630) | |
| ended use | They are motor driven, indoor and outdoor transportation vehicle with the intended use to providemobility to a disabled or elderly person limited to a seated position. | |
| Maximum load capacity | 127 kg (280 lbs) | 150 kg (330 lbs) |
| Overall dimension | ||
| Height | 921 mm (36.3") | 1250 mm (49.2") |
| Length | 1080 mm (43.5") | 1240 mm (48.8") |
| Width | 520 mm (20.5") | 560 mm (22") |
| Seat Overall dimension | ||
| Height | 550 mm (21.7") (from ground) | 756 mm (29.8") |
| Width | 427 mm (16.8") | 455 mm (17.9") |
| Depth | 350 mm (13.8") | 400 mm (15.7") |
| Seat / Seat cushion / Backrest | ||
| Material | PU foam covered by nylon fabric cloth | |
| Motor | ||
| Rated power | 250 W | 350 W |
| Input voltage | DC 24V | |
| Amount | 1 Pc | |
| Brake system | Intelligent regenerative electromagnetic brake and hand brake | |
| Controller | PG S-Drive, 45A | KYSA 70 |
| Differential mechanism | Differential rate: 19.7 : 1 | |
| Rear wheel drive | Sealed transaxle direct drive | |
| (Continuous) | The substantial equivalence comparison of the EQ 20C and EQ 30 (K072630) | |
| EQ 20C | EQ30 (K072630) | |
| Free-wheel mode | Yes | |
| Braking distance | Forward:1.0 m (39.4") at max speed | Forward: 1.24 m (48.8") at max speed |
| Net weight with battery | 55.5 kg (122 lbs) | 84.4 kg(185.7 lbs) |
| Slope grade ability | 8 degree | 10 degree |
| Per-charge distance | Up to 21 km (13 miles) | Up to 37 km (23.1 miles) |
| Maximum speed | Up to 6.5 km/h (4.1 mph) , variable | Up to 8 km/hr (4.7 mph), variable |
| Speed mode | Single mode, Variable | |
| Turning radius | 1200 mm (47.2") | 1565 mm (61.6") |
| Maximum curb height | 50 mm (2") | 80 mm (3.14") |
| Suspension | Front: No, Rear: Yes | |
| Head/Tail lightsSignal light | Head/tail lights and signal lights of the EQ 20C, and EQ 30 scooters have the same functions, butonly the styles are different. | |
| Warning light | Yes | |
| Horn | Yes | |
| Anti-tip wheels | Yes | |
| Operation mode | Thumb operated potentiometer throttle control lever | |
| Armrest | Yes, Foldable | |
| Tiller foldable | Yes | |
| Headrest | No | Yes |
| Height adjustable | No | Yes |
| Continuous) | The substantial equivalence comparison of the EQ 20C and EQ 30 (K072630) | |
| EQ 20C | EQ30 (K072630) | |
| Battery | ||
| Type | Lead-acid | |
| Rated power | 22 Ah | 31 Ah |
| Output voltage | 24 VDC | |
| Amount | DC 12V x 2 Pcs | |
| Battery level indicator | Yes | |
| Charger | ||
| Type | on-board, Automatic Type | |
| Input power requirement | 115-230 VAC | |
| Output voltage / current | DC 24V/5A | |
| Front wheels | ||
| Diameter | 70 mm/62.5 mm - 100 mm(2.8"/2.5"-4") | 250 mm x 125 mm(10" x 5") |
| type | non-pneumatic tires | |
| Material | Polyurethane (PU) | |
| Amount | 2 | |
| Rear wheels | ||
| Diameter | 70 mm/62.5 mm - 100 mm(2.8"/2.5"-4") | 250 mm x 125 mm(10" x 5") |
| type | non-pneumatic tires | |
| Material | Polyurethane (PU) | |
| Amount | 2 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WQ66-G609 Silver Spring, MD 20993-0002
October 7, 2013
Kwang Yang Motor Co., Ltd. c/o Mrs. Junnata Chang 16F-2(16A), No. 462, Sec. 2. ChongDe Rd. Beitun Dist. Taichung CHINA (Taiwan) 406
Re: K 130940
Trade/Device Name: Kymco EO 20C scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 15, 2013 Received: August 22, 2013
Dear Junnata Chang:
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 10 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 cither 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 arrated 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Junnata Chang
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting 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): K130940
Device Name: KYMCO EQ 20C SCOOTER
Indications For Use:
The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ___ × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Victor Krauthamer -S 2013.10.04 19:07:38 -04'00'
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§ 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).