(303 days)
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 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.
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 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.
The document provided is a 510(k) Premarket Notification for a medical device (a scooter) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study for the device's performance against predefined acceptance criteria using AI. Therefore, much of the requested information (e.g., sample sizes for test sets, number of experts for ground truth, MRMC study details, training set information) is not available in this document as it pertains to AI/algorithm performance studies, which are not relevant to this type of device submission.
However, the document does contain "Non-Clinical Test Conclusion" and "Table 4 Test results of ISO 7176 series comparison" which can be interpreted as acceptance criteria and their fulfillment through testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally implied by adherence to various ISO 7176 series standards, which define test methods and requirements for wheelchairs and scooters. The "Remarks" column in Table 4 (Safety Comparison) indicates "SE" (Substantially Equivalent), meaning the proposed device's performance meets or is comparable to the predicate devices in these aspects, and thus implicitly meets the requirements of the standards.
| Acceptance Criteria (Standard & Section) | Reported Device Performance (K182471) |
|---|---|
| Static stability (ISO 7176-1) | Test results meet design specification. |
| Dynamic stability (ISO 7176-2) | Test results meet design specification. |
| Effectiveness of brakes (ISO 7176-3) | Test results meet design specification. |
| Theoretical distance range (ISO 7176-4) | Test results meet design specification. |
| Dimensions, mass (ISO 7176-5) | Determined after testing. |
| Maximum speed, acceleration, deceleration (ISO 7176-6) | Determined after testing. |
| Seating and wheel dimensions (ISO 7176-7) | Determined after testing. |
| Static, impact, and fatigue strengths (ISO 7176-8) | All test results meet requirements in Clause 4 of ISO 7176-8. |
| Climatic tests (ISO 7176-9) | Device continued to function according to manufacturer's specification after testing. |
| Obstacle-climbing ability (ISO 7176-10) | Determined after testing. |
| Test dummies (ISO 7176-11) | Test dummies used meet requirements of ISO 7176-11. |
| Coefficient of friction of test surfaces (ISO 7176-13) | Determined. |
| Power and control systems (ISO 7176-14) | All test results meet requirements in Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| Information disclosure, documentation, labeling (ISO 7176-15) | Test results show compliance with requirements. |
| Resistance to ignition of postural support devices (ISO 7176-16) | Performance meets requirements. |
| Electromagnetic compatibility (ISO 7176-21) | EMC performance results meet requirements. |
| Set-up procedures (ISO 7176-22) | All performed tests are set up as per requirements. |
| Batteries and chargers (ISO 7176-25) | Performance meets requirements in Clause 5 and 6 of ISO 7176-25. |
| Biological evaluation - In Vitro cytotoxicity (ISO 10993-5) | (Implied compliance in "Biocompatibility" row of Table 2 - "Comply with ISO 10993-1") - Specific ISO 10993-5 states "Comply with ISO 10993-1", typically referring to the full series, and then specifically listing 10993-5 and 10993-10 on page 6. Therefore, it is assumed to comply. |
| Biological evaluation - Irritation and skin sensitization (ISO 10993-10) | (Implied compliance in "Biocompatibility" row of Table 2 - "Comply with ISO 10993-1") - Consistent with explanation for ISO 10993-5. Therefore, it is assumed to comply. |
| (General Safety - EMC) | Comply with IEC 60601-1-2 and ISO 7176-21. |
| (General Safety - Biocompatibility) | Comply with ISO 10993-1. |
| (General Safety - Label and Labeling) | Conforms to FDA Regulatory Requirements. |
2. Sample size used for the test set and the data provenance:
- Sample size used for the test set: Not explicitly stated. The tests refer to the device itself, implying a small number of physical units (likely one or a few prototypes) were subjected to the tests described in the ISO standards. This is typical for physical device testing, not statistical sampling of data.
- Data provenance: The tests were non-clinical, conducted to verify the device met design specifications and was substantially equivalent to predicate devices. The data originates from the manufacturer's own testing as part of the 510(k) submission process. There is no information on country of origin of the data beyond the manufacturer being in China. The testing would be considered "prospective" in the sense of being performed specifically for this submission, rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical scooter, not an AI or diagnostic tool requiring expert ground truth for interpretation. The ground truth for these tests is defined by the objective measurement criteria and performance limits described in the ISO standards themselves.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements against defined standards, not subjective interpretations requiring adjudication.
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 document is for a physical medical device (scooter), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical medical device (scooter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is the established requirements and test methods defined by the referenced ISO standards (e.g., ISO 7176 series, ISO 10993 series). Device performance is measured against these objective criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-based device, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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.
{5}------------------------------------------------
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.
-
- 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 DeviceK182471 | Predicate Device #1K172440 | Predicate Device #2K162952 | 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 ForUse | 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 |
| OperationEnvironment | 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 | ||
| OverallDimensions | 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 |
| SafeGradient/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 (notincluding 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-Normaloperation(Horizontal-Forward-Max speed) | 1m/39.4" | No available data | 1.3m/51.2" | Analysis |
| Time to brake | < 1 s | No available data | No available data | Analysis |
| Operating surface&environment | Indoor use and restricted outdoor use on pavementsor paved footpaths only. | Indoor and outdoor use | Indoor and outdoor use | SE |
| Frame material | Carbon steel | No available data | No available data | Analysis |
| Frame style | Foldable seat, removable battery pack, disassemblefor transport | adjustable steering column, removable battery pack,fold for transport | Disassemble for transport | SE |
| Frame tube size | ⌀25.4 | No available data | No available data | Analysis |
| Obstacle ClimbingAbility | 50 mm/1.97" | 38 mm/1.5" | 52 mm/2" | Analysis |
| MaximumCapacity | 120 kg/265 lbs approx | 125 kg/276 lbs Approx. | 136 kg/300 lbs | Analysis |
| Ground Clearance | 45 mm/1.8" | 36 mm/1.4" | 40mm/1.6" | Analysis |
| Battery | lead-acid 24V/12AH | Lithium battery 24 V/10AH | Lead-Acid 12V/22Ah x 2 | Analysis |
| Motor | 24 V 180W | 24V 120W | No available data | Analysis |
| Battery Charger | DC 24V/2A | DC 24V/2A | DC 24V/5A | SE |
| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark |
| K182471 | K172440 | K162952 | ||
| Performance Test | Comply with ISO 7176 series | Comply with ISO 7176 series | Comply with ISO 7176 series | SE |
| EMC | Comply with IEC 60601-1-2 and ISO 7176-21 | Comply with ISO 7176-21 | Comply with ISO 7176-21 | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label andLabeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | SE |
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Difference Analysis:
The design and technological characteristics of the is basically similar to the predicate device chosen. There are ninor differences between the devices including overall dimensions, tire size, basic weight, battery weight, brake distance, ime to brake, obstacle climbing ability, Maximum capacty, Ground clearance, Battery and motor. There is no cffectiveness due to the differences, and these minor differences do not influence the intended use finetion and use of the device, the non-clinical tests and the predicate comparisons chat these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.
Therefore, the subject device is substantially equivalent to the Solax Electric Scooter (K172440) and C.T.M. Mobility Scooter (K162952).
Table 3Safety Comparison
Table 4 Test results of ISO 7176 series comparison
| ITEM | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark | |
|---|---|---|---|---|---|
| K182471 | K172440 | K162952 | |||
| ISO 7176-1 | The Static stability has been determined after thetesting according to the ISO 7176-1, and test resultsmeet it's design specification. | The Static stability has been determined after thetesting according to the ISO 7176-1, and test resultsmeet it's design specification. | The Static stability has been determined after thetesting according to the ISO 7176-1, and test resultsmeet it's design specification. | SE | |
| ISO 7176-2 | The dynamic stability has been determined after the | The dynamic stability has been determined after the | The dynamic stability has been determined after the | SE | |
| testing according to the ISO 7176-2, and test resultsmeet it's design specification. | testing according to the ISO 7176-2, and test resultsmeet it's design specification. | testing according to the ISO 7176-2, and test resultsmeet it's design specification. | |||
| ISO 7176-3 | The effectiveness of brakes has been determined afterthe testing according to the ISO 7176-3, and testresults meet it's design specification. | The effectiveness of brakes has been determined afterthe testing according to the ISO 7176-3, and testresults meet it's design specification. | The effectiveness of brakes has been determined afterthe testing according to the ISO 7176-3, and testresults meet it's design specification. | SE | |
| ISO 7176-4 | The theoretical distance range has been determinedafter the testing according to the ISO 7176-4, and testresults meet it's design specification. | The theoretical distance range has been determinedafter the testing according to the ISO 7176-4, and testresults meet it's design specification. | The theoretical distance range has been determinedafter the testing according to the ISO 7176-4, and testresults meet it's design specification. | SE | |
| ISO 7176-5 | The dimensions, mass has been determined after thetesting according to the ISO 7176-5, | The dimensions, mass has been determined after thetesting according to the ISO 7176-5, | The dimensions, mass has been determined after thetesting according to the ISO 7176-5, | SE | |
| ISO 7176-6 | The maximum speed, acceleration and deceleration ofscooter has been determined after the testingaccording to the ISO 7176-6, | The maximum speed, acceleration and deceleration ofscooter has been determined after the testingaccording to the ISO 7176-6, | The maximum speed, acceleration and deceleration ofscooter has been determined after the testingaccording to the ISO 7176-6, | SE | |
| ISO 7176-7 | The seating and wheel dimensions has beendetermined after the testing according to the ISO7176-7, | The seating and wheel dimensions has beendetermined after the testing according to the ISO7176-7, | The seating and wheel dimensions has beendetermined after the testing according to the ISO7176-7, | SE | |
| ISO 7176-8 | All test results meet the requirements in Clause 4 ofISO 7176-8 | All test results meet the requirements in Clause 4 ofISO 7176-8 | All test results meet the requirements in Clause 4 ofISO 7176-8 | SE | |
| ISO 7176-9 | The test results shown that the device under testscould continue to function according tomanufacturer's specification after being subjected toeach of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under testscould continue to function according tomanufacturer's specification after being subjected toeach of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under testscould continue to function according tomanufacturer's specification after being subjected toeach of the tests specified in Clause 8 of ISO 7176-9 | SE | |
| ISO 7176-10 | The obstacle-climbing ability of device has beendetermined after the testing according to the ISO7176-10, | The obstacle-climbing ability of device has beendetermined after the testing according to the ISO7176-10, | The obstacle-climbing ability of device has beendetermined after the testing according to the ISO7176-10, | SE | |
| ISO 7176-11 | The test dummies used in the testing of ISO 7176 | The test dummies used in the testing of ISO 7176 | The test dummies used in the testing of ISO 7176 | SE | |
| series are meet the requirements of ISO 7176-11 | series are meet the requirements of ISO 7176-11 | series are meet the requirements of ISO 7176-11 | |||
| ISO 7176-13 | The coefficient of friction of test surfaces has been | The coefficient of friction of test surfaces has been | The coefficient of friction of test surfaces has been | SE | |
| determined, which could be used in other 7176 series | determined, which could be used in other 7176 series | determined, which could be used in other 7176 series | |||
| tests involved | tests involved | tests involved | |||
| ISO 7176-14 | All test results meet the requirements in Clause 7, 8, | All test results meet the requirements in Clause 7, 8, | All test results meet the requirements in Clause 7, 8, | SE | |
| 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | |||
| ISO 7176-15 | The test results shown that information disclosure, | The test results shown that information disclosure, | The test results shown that information disclosure, | SE | |
| documentation and labelling of device meet the | documentation and labelling of device meet the | documentation and labelling of device meet the | |||
| requirements of ISO 7176-15 | requirements of ISO 7176-15 | requirements of ISO 7176-15 | |||
| ISO 7176-16 | The performance of resistance to ignition meet the | The performance of resistance to ignition meet the | The performance of resistance to ignition meet the | SE | |
| requirements of ISO 7176-16 | requirements of ISO 7176-16 | requirements of ISO 7176-16 | |||
| ISO 7176-21 | The EMC performance results meet the requirements | The EMC performance results meet the requirements | The EMC performance results meet the requirements | SE | |
| of ISO 7176-21 | of ISO 7176-21 | of ISO 7176-21 | |||
| ISO 7176-22 | All performed tests are set up as requirements of ISO | All performed tests are set up as requirements of ISO | All performed tests are set up as requirements of ISO | SE | |
| 7176-22 | 7176-22 | 7176-22 | |||
| ISO 7176-25 | The performance of batteries and charger of device | The performance of batteries and charger of device | The performance of batteries and charger of device | SE | |
| meet the Requirements in Clause 5 and 6 of ISO | meet the Requirements in Clause 5 and 6 of ISO | meet the Requirements in Clause 5 and 6 of ISO | |||
| 7176-25 | 7176-25 | 7176-25 |
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10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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).