(186 days)
Not Found
No
The device description and summary of performance studies focus on standard mechanical and electrical components and compliance with mobility device standards, with no mention of AI or ML.
No
A therapeutic device is typically involved in the treatment, prevention, or diagnosis of a disease or condition. This device is a mobility aid for daily living, not a therapeutic intervention.
No
The device is a mobility scooter designed to provide transportation, not to diagnose medical conditions or diseases.
No
The device description clearly outlines numerous hardware components including a platform, wheels, batteries, charger, motor, brake assembly, controller, and seat.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with mechanical and electrical components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease, condition, or predisposition)
- Use in a laboratory or clinical setting for diagnostic testing
The device is clearly described as a mobility aid, which falls under a different category of medical devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
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.
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
disabled or elderly person
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)
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.
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
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
1
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.
2
| 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 provide | |
| mobility 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 lights | ||
| Signal light | Head/tail lights and signal lights of the EQ 20C, and EQ 30 scooters have the same functions, but | |
| only 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.
6
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
7
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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