(303 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard mobility scooter and does not mention any AI or ML capabilities.
Yes
The device is intended to provide mobility to disabled or elderly persons, which is a therapeutic purpose.
No
The device is described as an electric scooter intended to provide mobility to disabled or elderly individuals. Its function is transportation, not the diagnosis of any medical condition or disease.
No
The device description clearly outlines a physical, motor-driven vehicle with numerous hardware components (frame, wheels, motor, battery, etc.). It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a "motor driven, indoor and outdoor transportation vehicle" intended to provide mobility. It is a physical aid for transportation, not a tool for analyzing biological samples.
- Lack of Biological Specimen Interaction: The description does not mention any interaction with biological specimens or any analytical processes related to human health markers.
- Intended Use: The intended use is for mobility, not for diagnosis or monitoring of a medical condition through analysis of biological samples.
The device described is a mobility scooter, which falls under a different category of medical devices (likely a Class II device related to physical medicine).
N/A
Intended Use / Indications for Use
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.
Product codes
INI
Device Description
The Scooter (Models: KPL001) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, rechargeable lead-acid battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The parts of Scooter, such as seat, rear, basket, batteries cover, could be disassembled easily. No tools will need in installation or uninstallation.
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2001, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, ISO 10993-5: 2009, ISO 10993-10: 2010.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 10, 2019
Tianjin Kepler Vehicle Industry Co. Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 Cn
Re: K182471
Trade/Device Name: Scooter KPL001 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 9, 2019 Received: April 11, 2019
Dear Ray Wang:
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 aware 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
1
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 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,
Vivek Pinto, PhD Assistant Director 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
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Indications for Use
510(k) Number (if known) K182471
Device Name Scooter, Model: KPL001
Indications for Use (Describe)
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.
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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This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K182471
-
Date of Preparation 1.
07/10/2019 -
- Sponsor
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.
Xinmin Road, West Area of Economic and Technological Development Zone, TianJin 300462, China Contact Person: ChunXi Zhang Position: General Manager Tel: +86 22 61027905 Fax: +86 22 61027908 Email: allen.zhang@kepler-vehicle.com
-
- Submission Correspondent
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Tel: +86-21-68828050 Fax: +86-21-58597193 Email: ray.wang(@believe-med.com
- Submission Correspondent
4
4. Identification of Proposed Device
Trade Name: Scooter Common Name: vehicle, motorized 3-wheeled Model(s): KPL001
Regulatory Information: Classification Name: vehicle, motorized 3-wheeled Classification: 2; Product Code: INI; Regulation Number: 21 CFR 890.3800; Review Panel: Physical Medicine;
Intended Use Statement:
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 Scooter (Models: KPL001) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, rechargeable lead-acid battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.
- Device Description
The parts of Scooter, such as seat, rear, basket, batteries cover, could be disassembled easily. No tools will need in installation or uninstallation.
The Scooter could be detached as following steps:
- Before operating, the knob is in the horizontal direction, then Push the lock konb forward and a. point to the key hole ,turn it 90 degree clockwise, the tiller will be locked in a straight ahead position.
- Separating the seat from the scooter by lifting up the seat. If the seat is blocked while you are b. removing it, please loosen the seat while lifting it and turn the seat back.
- Separating the batteries from the scooter by lifting up the battery pack. C.
And, the scooter could be installed as following steps:
- Firstly, use the quick release handle to lift the frame. a.
- b. Then, put the motor support forward, the frame hook is correctly attached to the tube.
- Turn the tiller to a high position and tighten the tiller button. C.
- d. The re installation of the batteries.
- Reinstalling the seat, and turning it until it is fixed in right place. e.
- f. The counterclockwise rotation of a knob, unlock the tiller.
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6. Identification of Predicate Device
Predicate #1 510(k) Number: K172440 Product Name: Solax Electric Scooter Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.
Predicate #2 510(k) Number: K162952 Product Name: C.T.M. Mobility Scooter Manufacturer: Chien Ti Enterprise Co., Ltd.
Non-Clinical Test Conclusion 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability.
ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
ISO 7176-3:2012 Wheelchairs – Part 3: Determination of effectiveness of brakes.
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and manoeuvring space.
ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs – Part 7: Measurement of seating and wheel dimensions.
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
ISO 7176-9:2009 Wheelchairs – Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs – Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs – Part 11: Test dummies.
ISO 7176-13:1989 Wheelchairs – Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test method.
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
ISO 7176-16:2012 Wheelchairs – Part 16: Resistance to ignition of postural support devices.
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2014 Wheelchairs – Part 22: Set-up procedures
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ISO 7176-25:2013 Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
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- Clinical Test Conclusion
No Clinical Test conducted.
- Clinical Test Conclusion
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9. Substantially Equivalent (SE) Comparison
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | |||
| K182471 | Predicate Device #1 | |||
| K172440 | Predicate Device #2 | |||
| K162952 | Remark | |||
| Product Code | INI | INI | INI | SE |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | 21 CFR 890.3800 | SE |
| Class | 2 | 2 | 2 | SE |
| Indication For | ||||
| Use | 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. | 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. | The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person. | SE |
| Operation | ||||
| Environment | For Indoor/Outdoor use | For Indoor/Outdoor use | For Indoor/Outdoor use | SE |
Table 1 General Comparison
Table 2 Performance Comparison
| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark |
|---|---|---|---|---|
| K182471 | K172440 | K162952 | ||
| Overall | ||||
| Dimensions | 1030mm/40.6" x 630mm/24.8" x 920mm/36.2" | 930mm/36.6" x 450mm/17.7" x 865mm/34.1" | 1120mm/44" x 590mm/23.2" x 935mm/36.8" | Analysis |
| Tires | 7" (190 x 54 mm) for front wheel (solid wheel) | |||
| 8" (215 x 70 mm) for rear wheel (solid wheel) | 6 inches (160 x 45 mm) for front wheel (solid wheel) | |||
| 7 inches (190 x 70 mm) for rear wheel (solid wheel) | Front wheels: 225mm/9" | |||
| Rear wheels: 225mm/9" | Analysis | |||
| Speed | 6.6 km/h | 6 kmh/3.7 mph | 8 kmh/ 5 mph | Analysis |
| Safe | ||||
| Gradient/Maximum Gradient | 8° | SE | ||
| Range | 15 km/9.32 Miles | 15 km / 9.32 Miles | 17.5 kg / 10.9 Miles | SE |
| Turning Circle | 1.3 m/51.2" | 1.55 m/61" | 1.45m/57.1" | Analysis |
| Base weight (not | ||||
| including battery) | 50 kg/110 lbs | 24 kg/ 53 lbs | 55kg/121.3 lbs | Analysis |
| Battery Weight | 10.2 kg/22.5 lbs | 1.84 kg/4.1 lbs | 15.5 kg/34.2 lbs | Analysis |
| Brake | Electromagnetic | Electromagnetic | Electromagnetic | SE |
| Drive System | Rear wheel drive | Rear wheel drive | Rear wheel drive | SE |
| Distance-Normal | ||||
| operation | ||||
| (Horizontal-Forward-Max speed) | 1m/39.4" | No available data | 1.3m/51.2" | Analysis |
| Time to brake |