(121 days)
Not Found
No
The description details a standard electric scooter with mechanical and electrical components, with no mention of AI or ML capabilities.
No.
The device is described as an indoor transportation vehicle to provide mobility, rather than to treat or cure a medical condition.
No
The device is described as an indoor transportation vehicle designed to provide mobility for disabled or elderly persons, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines numerous hardware components including wheels, a platform, tiller, batteries, charger, motor/electromagnetic brake assembly, electric motor controller, and a seat/backrest. This is a physical device, not software only.
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 for movement and control. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological material. There is no mention of diagnostic purposes, disease detection, or monitoring of health conditions through laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes
INI
Device Description
The EQ10D 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 off-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 scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.
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)
Summary of non-clinical testing: The EQ10D scooter complied with the requirements of ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ANSI/RESNA WC Vol. 2 Sec. 21, ISO 7176-25, ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
Kwang Yang Motor Co., Ltd. % Mrs. Junnata Chang No. 35. Wan Hsing Street, San Min Dist. Kaohsiung 803 Taiwan
Re: K163201
Trade/Device Name: KYMCO EO10D Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: February 5, 2017 Received: February 16, 2017
Dear Mrs. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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.
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) K163201
Device Name KYMCO EQ10D Scooter
Indications for Use (Describe)
The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Type of Use (Select one or both, as applicable)
| ☑ Registration Use (Part 21 CFR 801 Subpart D) |
|---|
| ☑ Over-The-Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safetv 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: Wang Ching Yun Phone: +886-7-3822526 Fax: +886-7-3825834 e-mail: kymcoreg(@mail.kymco.com Date prepared: Jan. 15, 2017 Device Trade name: KYMCO EQ10D 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 20C 510(k) number: K130940 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.
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Device description:
The EQ10D 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 off-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 scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.
Summary of non-clinical testing
The EQ10D scooter complied with the requirements of ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ANSI/RESNA WC Vol. 2 Sec. 21, ISO 7176-25, ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 14971.
Statement of substantial equivalence
The EQ10D scooter is substantially equivalent to the EQ 20C (K130940). 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.
The EQ10D is substantially equivalent to the KYMCO EQ 20C (K130940) manufactured by KWANG YANG MOTOR CO. LTD.. 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. They are 4-wheeled scooters with basic conventional rear wheel drive which with free-wheel mode. The motor of both devices is equipped with differential mechanism, which the differential rate is 19.7:1. The anti-tip wheels are equipped
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behind the rigid frame of both devices. The power supply of both devices is self-contained lead-acid batteries to provide power that can be recharged by a charger that can be plugged into an AC outlet when the devices are not in use. The horn and foldable armrests are also equipped on both devices.
Both devices have the same user interface, the patient uses the foldable 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. The speed mode of the both devices was single mode and the speed control dial can control the maximum speed. Both seats of the devices are equipped with removable flip-up armrest and there is no headrest on backrest. Seat cushions and backrests of both devices used the same materials, which is PU foam covered by nylon fabric cloth. The seat, seat cushion, backrest, handlebar and throttle control lever of the device will contact to the patient. The materials of the patient contacting parts used for the EQ10D scooter and predicate device are exactly same and no additional processing different from predicate device, so no new safety and efficacy concerning.
The predicate device is equipped with head light, tail light, signal light and warning light, which EQ 10D does not. There are warn labels in the EQ10D user manual that remind users do not ride the scooter at night in case of danger, because the scooter does not equipped head light, tail light, signal light and warning light, so do not raise any questions as to the safety.
The main difference for the two devices is the rated power of the used batteries, the rated power of the motor, battery charger type, lights and the maximum speed. While there are minor differences between the devices including dimensions, wheels size and pre-charging distance, 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 Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, KWANG YANG MOTOR CO., LTD. concludes that, EQ10D scooter is substantially equivalent to predicate devices as described herein.
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| EQ 20C (K130940) | EQ10D | Comparison to the predicate device | ||
|---|---|---|---|---|
| Indications for 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. | Same indications for use | |||
| Maximum load capacity | 127 kg (280 lbs) | 125 kg (275 lbs) | Smaller load capacity | |
| ISO 7176-5 | ||||
| Overall length | 1080 mm (43.5") | 1020 mm (40.2") | Smaller overall length | |
| Overall width | 520 mm (20.5") | 377 ~ 500 mm | ||
| (14.8 ~ 19.7") | Smaller overall width | |||
| Handgrip height | 88 cm(34.6") | 89 cm(35") | Larger handgrip height | |
| Stowage length | 106 cm(41.7") | 102 cm(40.2") | Smaller stowage length | |
| Stowage width | 510 mm(20.1") | 487 mm(19.2") | Smaller stowage width | |
| Stowage height | 450 mm(17.7") | 940 mm(37") | Larger stowage height | |
| Rising | 150 mm(5.9") | 105 mm(4.1") | Smaller rising | |
| Total mass | with battery : 55.5 kg (122 lbs) | |||
| without battery : 45 kg(99 lbs) | with battery : 43 kg(94.6 lbs) | |||
| without battery : 33 kg (72.6 lbs) | Lighter mass | |||
| Mass of heaviest part | 20.5 kg (45.2 lbs) body frame | |||
| with motor | 14 kg(30.8 lbs) body frame with | |||
| motor | Lighter mass of heaviest part | |||
| Pivot width | 250 cm(98.4") | 150.5 cm(59.3") | Smaller pivot width | |
| Reversing width | 160 cm(63") | 233 cm(91.7") | Larger reversing width | |
| (Continuous) The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | ||||
| EQ 20C (K130940) | EQ10D | Comparison to the | ||
| predicate device | ||||
| Turning diameter | 250 cm(98.4") | 242 cm(95.2") | Smaller turning diameter | |
| Ground clearance | 60 mm(2.4") | 50 mm(2") | Smaller ground clearance | |
| Required width of angled corridor | 120 cm(47.2") | 106.5 cm(41.9") | Smaller required width of | |
| angled corridor | ||||
| Required doorway entry depth | 106 cm(41.7") | 60 cm(23.6") | Smaller required doorway | |
| entry depth | ||||
| Required corridor width for side | ||||
| opening | 190 cm(74.8") | 110 cm(43.3") | Smaller required corridor | |
| width for side opening | ||||
| ISO 7176-7 | ||||
| Seat plane angle | 5° | 2° | Smaller seat plane angle | |
| Effective seat depth | 350 mm(13.8") | 483 mm (19") | Larger effective seat depth | |
| Seat width | 350 mm(13.8") | 400 mm (15.7") | Larger seat width | |
| Effective seat width | 307 mm ~ 430 mm | |||
| (12" ~ 17") | 327 mm ~ 450 mm | |||
| (12.8" ~ 18") | Larger effective seat width | |||
| Seat surface height at front edge | 440 mm~516 mm | |||
| (17.3"~20.3") | 445 ~ 521 mm | |||
| (17.5" ~ 20.5") | Larger seat surface height at | |||
| front edge | ||||
| Back support angle | 12° | 15° | Larger back support angle | |
| Back support height | 395 mm(15.6") | 290 mm(11.4") | Smaller back support height | |
| Back support width | 350 mm(13.8") | 400 mm (15.7") | Larger back support width | |
| (Continuous) | The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | |||
| EQ 20C (K130940) | EQ10D | Comparison to the predicate device | ||
| Foot support to seat distance | 345 ~ 421 mm | |||
| (13.6" ~ 16.6") | 370 ~ 446 mm | |||
| (14.6" ~ 17.6") | Both devices are adjustable | |||
| Foot support clearance | 70 mm(2.8") | 50 mm(2") | Smaller foot support clearance | |
| Arm support height | 155 mm(6.1") | 180 mm(7.1") | Larger arm support height | |
| Front of arm support to back support | 250 mm(9.8") | 350 mm(13.8") | Larger front of arm support to back support | |
| Arm support length | 260 mm(10.2") | 300 mm(11.8") | Larger arm support length | |
| Arm support width | 50 mm(2") | Same arm support width | ||
| Arm support angle | 0° | Same arm support angle | ||
| Distance between arm supports | 420 mm(16.5") | 377 mm ~ 500 mm | ||
| (14.8"~19.7") | Distance between arm supports is adjustable | |||
| (Continuous) | The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | |||
| EQ 20C (K130940) | EQ10D | Comparison to the | ||
| predicate device | ||||
| Horizontal location of the wheel axle | 219 mm(8.6") | 283 mm(11.4") | Larger horizontal location of the wheel axle | |
| Vertical location of the wheel axle | 284 mm(11.2") | 277 mm(10.9") | Smaller vertical location of the wheel axle | |
| Material | PU foam covered by nylon fabric cloth | Same materials | ||
| Seat | ||||
| Seat cushion | ||||
| Backrest | ||||
| Differential mechanism | Differential rate: 19.7 : 1 | Same differential mechanism | ||
| Both devices have free- wheel | ||||
| Free-wheel mode | Yes | mode | ||
| Speed mode | Single mode, Variable | Same speed mode | ||
| Lights | ||||
| Head/Tail lights | Yes | No | Without head/tail lights | |
| Signal light | Yes | No | Without signal light | |
| Warning light | Yes | Both devices have warning light | ||
| Horn | Yes | Both devices have horn | ||
| (Continuous) | The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | |||
| EQ 20C (K130940) | EQ10D | Comparison to the predicate device | ||
| Anti-tip wheels | Yes | Both devices have anti-tip wheels | ||
| Operation mode | Thumb operated potentiometer throttle control lever | Same operation mode | ||
| Armrest | Removable flip-up armrest | Same type armrest | ||
| Tiller foldable | Yes | Same type tiller | ||
| Headrest | No | Both device without headrest | ||
| Motor | ||||
| Rated power | 250 W | 270 W | Larger rated power | |
| Input voltage | DC 24V | Same input voltage | ||
| Amount | 1 Pc | Same amount | ||
| Brake system | Intelligent regenerative electromagnetic brake and hand brake | Same type brake system | ||
| Controller | PG S-Drive, 45A | Same controller | ||
| Rear wheel drive | Sealed transaxle direct drive | Same type drive | ||
| Braking distance(at max speed) | Forward:1.0 m (39.4") | Forward: 1.1 m (43.3") | Larger braking distance | |
| Per-charge distance | Up to 21 km (13 miles) | Up to 16 km (10 miles) | Smaller per-charge distance | |
| Maximum speed | Up to 6.5 km/h (4.1 mph), variable | Up to 6.4 km/hr (4 mph), variable | Smaller max. speed | |
| Maximum curb height | 50 mm (2") | Same maxi. curb height | ||
| Suspension | Front: No, Rear: Yes | Same | ||
| (Continuous) | The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | |||
| EQ 20C (K130940) | EQ10D | Comparison to the predicate device | ||
| Battery | ||||
| Type | Lead-acid | Same type batteries | ||
| Rated power | 22 Ah | 24 Ah | Larger rated power | |
| Output voltage | 24 VDC | Same output voltage | ||
| Amount | DC 12V x 2 Pcs | Same amount | ||
| Battery level indicator | Yes | Both have battery level indicator | ||
| Charger | ||||
| Type | on-board, Automatic Type | off-board, Automatic Type | Different type | |
| Input power requirement | 115-230 VAC | Same input power | ||
| Output voltage / current | DC 24V / 5A | DC 24V / 2A | Same output voltage | |
| Smaller output current | ||||
| Front wheels | ||||
| Diameter | 70 mm/62.5 mm – 100 mm(2.8"/2.5"-4") | 7.5" × 2.35" | Larger diameter | |
| type | non-pneumatic tires | Same type tires | ||
| Material | Polyurethane (PU) | Same material | ||
| Amount | 2 | Same amount | ||
| (Continuous) | The substantial equivalence comparison of the EQ10D and EQ 20C (K130940) | |||
| EQ 20C (K130940) | EQ10D | Comparison to the predicate device | ||
| Rear wheels | ||||
| Diameter | 70 mm/62.5 mm – 100 mm(2.8"/2.5"-4") | 7.5" × 2.35" | Larger diameter | |
| type | non-pneumatic tires | Same type tires | ||
| Material | Polyurethane (PU) | Same material | ||
| Amount | 2 | Same amount |
The substantial equivalence comparison of the EQ10D and EQ 20C (K130940)
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