(417 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: FDB01) 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, 2 rechargeable Lithium-Ion 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 Scooter only can be operated on the flat road.
The provided document describes a 510(k) premarket notification for a Scooter (Model: FDB01). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than efficacy or clinical performance in terms of disease detection or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML-driven diagnostics will not be present.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are compliance with various international standards for wheelchairs and scooters, and the "reported device performance" is the statement that the device meets these standards. The device is not an AI/ML diagnostic and therefore does not have acceptance criteria in terms of sensitivity, specificity, or similar metrics.
| Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) | All user directly contacting materials are compliant with ISO 10993-5 requirements. |
| ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization) | All user directly contacting materials are compliant with ISO 10993-10 requirements. |
| Electrical / Electromagnetic Compatibility (EMC) | |
| ISO 7176-21:2009 (Electromagnetic compatibility) | The EMC performance results meet the requirements of ISO 7176-21. |
| Performance (Mechanical & Functional) | |
| ISO 7176-1: 2014 (Static stability) | The static stability has been determined after testing according to ISO 7176-1, and test results meet its design specification. |
| ISO 7176-2:2017 (Dynamic stability of Powered Wheelchairs) | The dynamic stability has been determined after testing according to ISO 7176-2, and test results meet its design specification. |
| ISO 7176-3: 2012 (Effectiveness of brakes) | The effectiveness of brakes has been determined after testing according to ISO 7176-3, and test results meet its design specification. |
| ISO 7176-4: 2008 (Energy consumption for theoretical distance range) | The theoretical distance range has been determined after testing according to ISO 7176-4, and test results meet its design specification. |
| ISO 7176-5: 2008 (Overall dimensions, mass and manoeuvring space) | The dimensions and mass have been determined after testing according to ISO 7176-5. |
| ISO 7176-6: 2018 (Maximum speed, acceleration and deceleration) | The maximum speed, acceleration, and deceleration have been determined after testing according to ISO 7176-6. |
| ISO 7176-7 (Measurement of seating and wheel dimensions) | The seating and wheel dimensions have been determined after testing according to ISO 7176-7. |
| ISO 7176-8:2014 (Static, impact and fatigue strengths) | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9:2009 (Climatic tests for Powered Wheelchairs) | The test results shown that the device could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9. |
| ISO 7176-10:2008 (Obstacle-climbing ability) | The obstacle-climbing ability of the device has been determined after testing according to ISO 7176-10. |
| ISO 7176-11:2012 (Test dummies) | The test dummies used in the testing of ISO 7176 series meet the requirements of ISO 7176-11. |
| ISO 7176-13: 1989 (Coefficient of test surfaces) | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. |
| ISO 7176-14:2008 (Power and control systems) | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| ISO 7176-15:1996 (Information disclosure, documentation and labeling) | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. |
| ISO 7176-16:2012 (Resistance to ignition of postural support devices) | The performance of resistance to ignition met the requirements of ISO 7176-16. |
| ISO 7176-25:2013 (Batteries and chargers for powered wheelchairs) | The performance of batteries and charger of device met the requirements in Clause 5 and 6 of ISO 7176-25. |
| Labeling | |
| Conforms to FDA Regulatory requirements for Label and Labeling | Conforms to FDA Regulatory. |
Study Information:
The study described is a non-clinical test program designed to demonstrate that the Scooter (Model: FDB01) meets established performance and safety standards, and is substantially equivalent to predicate devices. There are no clinical studies mentioned in this submission.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size" in the context of patients or cases, as this is a non-clinical device performance study. The testing refers to one Scooter (Model: FDB01) being subjected to various tests.
- Data Provenance: The tests were conducted to verify compliance with international standards (ISO series). The manufacturer is Nanjing Jin Bai He Medical Apparatus Co., Ltd, located in China. The testing itself is non-clinical, implying laboratory or controlled environment testing of the device specimen(s).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Experts: Not applicable. For non-clinical device performance testing against established standards, "ground truth" is determined by whether the device's physical and functional properties meet the numerical or qualitative requirements of the standard, as measured by calibrated equipment and documented test protocols. This isn't based on expert judgment in the way a diagnostic imaging study would be.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Device performance against ISO standards is typically assessed via objective measurements and adherence to specified test procedures, not through expert adjudication in the traditional sense of consensus reading or arbitration.
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:
- MRMC Study: No. This is a non-clinical submission for a medical device (scooter), not an AI/ML diagnostic or imaging device used by human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a motorized scooter, not a standalone AI algorithm. It is a physical device operated by a human user.
7. The Type of Ground Truth Used:
- Ground Truth: The "ground truth" for this device's performance is defined by the requirements and test methods outlined in the cited ISO 7176 series standards and ISO 10993 series standards. These standards specify how to measure various performance characteristics (e.g., static stability, brake effectiveness, dimensions, EMC) and the acceptable limits or conditions for those characteristics. The tests verify that the device's measured performance falls within these specified "ground truth" parameters.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not applicable. This is not an AI/ML device.
{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 & 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.
June 25, 2021
Nanjing Jin Bai He Medical Apparatus Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500#Central Ave. Shanghai, Shanghai 200122 China
Re: K201196
Trade/Device Name: Scooter (Model: FDB01) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 2, 2021 Received: April 2, 2021
Dear Ivy 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/cfpm/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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K201196
Device Name Scooter (Model: FDB01)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) Summary
Date of Preparation: 6/9/2021
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
A. Sponsor Information
Nanjing Jin Bai He Medical Apparatus Co., Ltd Address: No. 12, Wuge Rd, Jiangning, Nanjing City, Jiangsu, 211113, China Contact Person: Dandan Yang Tel: +86-25-85780899
Submission Correspondent
Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com
B. Subject device
| Trade Name: | Scooter (Model: FDB01) |
|---|---|
| Common Name: | Scooter |
| Classification Name: | Motorized three-wheeled vehicle |
| Product code: | INI |
| Classification: | II |
| Regulation Number: | 890.3800 |
| Review Panel: | Physical Medicine |
C. Predicate device
1st Predicate device (Primary):
| Sponsor | TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD. |
|---|---|
| Device Name | Scooter (KPL001) |
| 510Knumber | K182471 |
2nd Predicate device
| Sponsor | Dongguan Prestige Sporting Goods Co., Ltd |
|---|---|
| Device Name | Solax Electric Scooter |
| 510Knumber | K172440 |
D. 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.
{4}------------------------------------------------
E. Device Description
The Scooter (Models: FDB01) 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, 2 rechargeable Lithium-Ion 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 Scooter only can be operated on the flat road.
F. Non-Clinical Test Conclusion
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:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
- V ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
-
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
-
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
-
ISO 7176-5. Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
-
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
-
ISO 7176-7, 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
- A ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered 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. First edition 1989-08-01. Wheelchairs - Part 13: Determination of coefficient of test surfaces
-
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
-
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
- A ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
{5}------------------------------------------------
Table 1 General Comparison
| Characteristic | Subject Device(s) | Primary Predicate Device(K182471) | Secondary Predicate Device(K172440) | Justification forSubstantialEquivalence |
|---|---|---|---|---|
| Manufacturer | Nanjing Jin Bai He Medical Apparatus Co., Ltd | Tianjin Kepler Vehicle Industry Co. Ltd. | Dongguan Prestige Sporting Goods Co., Ltd. | NA |
| Device Name | Scooter | Scooter | Solax Electric Scooter | NA |
| Model(s) | FDB01 | KPL001 | S302421 | NA |
| Indication for use | It is a motor driven, indoor and outdoortransportation vehicle with the intended use toprovide mobility to a disabled or elderly personlimited to a seated position. | It is a motor driven, indoor and outdoortransportation vehicle with the intended use toprovide mobility to a disabled or elderly personlimited to a seated position. | It is a motor driven, indoor and outdoortransportation vehicle with the intended use toprovide mobility to a disabled or elderly personlimited to a seated position. | S.E. |
| Frame Material | Aluminum alloy | Aluminum alloy | Metal alloy | S.E. to K182471 |
| Frame Design / Style | Electric scooter is driven by electricity scooter, is atransportation tool and auxiliary tools for thepurpose of walking, without removing the batterycan be folded, easy to carry and storage. | Electric scooter is driven by electricity scooter, is atransportation tool and auxiliary tools for thepurpose of walking, without removing thebattery can be folded, easy to carry and storage. | Electric scooter is driven by electricity scooter, is a transportation tool and auxiliary tools for thepurpose of walking, without removing thebattery can be folded, easy to carry and storage. | S.E. |
| Folding Mechanism | Seat can be folded; battery can be dismantled; Theframe can be folded back and forth. | Seat cannot be folded; battery can bedismantled.It be dismantled foldable handlebar. | Seat can be folded; battery can be dismantled;The frame can be folded back and forth. | S.E. |
| Seating Design | One-click folding intelligent electric scooter, with asensitive remote control, gently press, the carautomatically completed folding contraction,folding volume small, electromagnetic automaticbrake, the overall simple design, convenient andpractical. Travel does not have to consume physicalforce to do folding, poor physical strength and theelderly the best walking tool.Image: [scooter folded] | Only foldable handlebarImage: [scooter folded] | One-click folding intelligent electric scooter,with a sensitive remote control, gently press, thecar automatically completed folding contraction,folding volume small, electromagneticautomatic brake, the overall simple design,convenient and practical, Travel does not haveto consume physical force to do folding, poorphysical strength and the elderly the bestwalking tool.Image: [scooter folded] | S.E. to K172440 |
| Seating Attachment -integrated, powerbase, specialty power | Without any seat accessories (integrated, powerbase, dedicated power supply) | Without any seat accessories (integrated, powerbase, dedicated power supply) | Without any seat accessories (integrated, powerbase, dedicated power supply) | S.E. |
| Overall Dimensions | 1050mm X 550mm X 870mm | 1030mm X 630mm X 920mm | 930mm X 450mm X 865mm | Similar |
| Length | 1050 | 1030mm | 930mm | Similar |
| Width | 550 | 630mm | 450mm | Similar |
| Height | 870 | 920mm | 865mm | Similar |
| Seat Dimensions | ||||
| Width | 438 | 420 | 430 | Similar |
| Depth | 385 | 350 | No data available | Similar |
| Height | 382 | 590 | 560 | Similar |
| Weight | 4kg | 11kg | No data available | Lighter then predicate |
| Folded Dimensions | ||||
| Length | 480mm | No data available | 450mm | Similar |
| Width | 550mm | 1030mm | 450mm | Similar |
| Height | 790mm | 550mm | 640mm | Similar |
| Wheelchair Weight | ||||
| With batteries | 29 | 50 | 24 | Similar to K172440 |
| Without batteries | 24.2 | 29.8 | 20.32 | Similar |
| Controller | British PG Controller PG45A | British PG Controller PG45A | British PG Controller PG45A | S.E. |
| Drive Style (e.g., rear,mid, front) | Rear-wheel drive | Rear wheel drive | Rear wheel drive | S.E. |
| Motor Type | 24V DC brush differential rear axle | 24V DC brush differential rear axle | 24V DC brush differential rear axle | S.E. |
{6}------------------------------------------------
{7}------------------------------------------------
| Motor Output | 24V 180W | 24V 180W | 24V 120W | S.E. to K182471 |
|---|---|---|---|---|
| Batteries | Lithium battery | Lead Acid | Lithium battery | S.E. to K172440 |
| Quantity | 2 | 2 | No available data | S.E. to K182471 |
| Type | 24V 6AH | 24V/12AH | 24V/10AH | Similar |
| Chemistry | Lithium battery | Lead Acid | Lithium battery | S.E. to K172440 |
| Range per Charge | 6 hours | between 6 and 8 hours | 8-14 hours | S.E. to K182471 |
| Charger Type (On-board/Off- board/Carry-on) | Carry-on | Carry-on | Carry-on | S.E. |
| Input/Output Power | 100-240VAC 50/60Hz 1.2.-0.5A | 100-240V~50/60Hz 1.2A 120VAOutput: 29V 2A | 24V 2A/OUTPUT: 29.4V 2A | S.E. to K182471 |
| Actuator | Intelligent, Regenerative andElectromagnetic brake system | Intelligent, Regenerative andElectromagnetic brake system | Intelligent, Regenerative andElectromagnetic brake system | S.E. |
| Brake | electromagnetic brake | electromagnetic brake | electromagnetic brake | S.E. |
| Minimum brakingdistance and time | 1.1 m for the speed of 6km/h1s | 1m for the speed of 6.6km/h<1s | No data available | S.E. to K182471 |
| Forward | 0~6km/h | 0~6.6km/h | 0~6km/h | S.E. |
| Reverse | 3km/h | No data available | No data available | NA |
| Wheel Lock (type) | electromagnetic brake | electromagnetic brake | electromagnetic brake | S.E. |
| Max speed | 6km/h | 6.6km/h | 6km/h | S.E. to K172440 |
| Forward | 6km/h | 0~6.6km/h | 0~6km/h | S.E. to K172440 |
| Reverse | 3km/h | No data available | No data available | NA |
| Rear Wheels Size | 8 inches for rear wheel (solid wheel) | 8" (215 x 70 mm) for rearwheel (solid wheel) | Tire Size Rear 7 x 2.36 in | Similar |
| Quantity | 2 | 2 | 2 | S.E. |
| Tire Pressure (if pneumatic) | NA | NA | NA | NA |
| Castors Size | 7inches for front wheel (solid wheel) | 7" (190 x 54 mm) for frontwheel (solid wheel) | Tire Size Front 6 x 1.5 in | Similar |
| Quantity | 2 | 2 | 2 | S.E. |
| Tire Pressure (if pneumatic) | NA | NA | NA | NA |
| Anti-tip Wheels | 2.5 inches | 2.5 inches | 2.5 inches | S.E. |
| Removable (Yes/No) | yes | yes | yes | S.E. |
| Style | \ | NA | NA | NA |
| Suspension (if applicable) | No | No | No | S.E. |
| Maximum Occupant Mass | 120KG | 120KG | 125kg Approx. | Similar |
| Curb Climbing ability | 60mm | 50mm | 38mm | Different |
| Ground clearance | 50mm | 110mm | 36mm | Different |
| Minimum Turning Radius | 1.2m | 1.3m | 1.55m | Different |
| Maximum Incline | Maximum safe operational incline for posteriorly is 20.1°Maximum safe operational incline for anteriorly is 30°Maximum safe operational incline for sideways is 15.3° | Static stability downhill 16°Static stability uphill 16°Static stability sideways 15°Dynamic Stability uphill 15° | 12° | Different |
| Footplates | ABS plastics | ABS plastics | ABS plastics | S.E. |
| Back Upholstery | Leather package | Artificial Leather | Artificial Leather | Different |
| Armrest Type | PU Foamed Arms | Artificial Leather | PU Foam | S.E. to K172440 |
| Operating surface &environment | Indoor and outdoor use | Indoor and outdoor use | Indoor and outdoor use | S.E. |
| Additional Accessory | Remote control key, hex wrenches, four-holewrench, power transfer connection, charger, usermanual | Charger, operation manual, allen wrench, open-end wrench | No data available | Similar |
| Warranty | Exist | Exist | Exist | S.E. |
{8}------------------------------------------------
{9}------------------------------------------------
Difference analysis:
The design and technological characteristics of the predicate chosen. There are minor differences between the devices including Size, tires, Safe Gradient Maximum Gradient, Travel distance on fully charged battery, Minimum turning radias, Battery weight, Battery amounts, Battery capacity, Maximum capacity, Ground clearance, Obstace, Chility, Color, Brake time, Clarge time, Maximum safe operational incline, Curb clearance, wireless technology, frame. All of the parameter with difference have been tested according to ISO7176 series support its safety and effectiveness. There is no deteriveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Scooter is substantially equivalent (SE) to the KPL001 Scooter (K182471) and Solax Electric Scooter (K172440).
| Item | Proposed Device | 1st Predicate Device (Primary) | 2nd Predicate Device | Results |
|---|---|---|---|---|
| Biocompatibility | All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements. | All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements. | All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements. | SE |
| EMC | ISO7176-21 | ISO7176-21 | ISO7176-21 | SE |
| Performance | ISO7176 series | ISO7176 series | ISO7176 series | SE |
| Label andlabeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
Table 3 Safety comparison
Table 4 Safety comparison
| Item | Proposed Device | 1st Predicate Device (Primary) | 2nd Predicate Device | Results |
|---|---|---|---|---|
| ISO7176-1 | The Static stability has been determined afterthe testing according to the ISO 7176-1, andtest results meet it's design specification. | The Static stability has been determined afterthe testing according to the ISO 7176-1, andtest results meet it's design specification. | The Static stability has been determined afterthe testing according to the ISO 7176-1, andtest results meet it's design specification. | SE |
| ISO7176-2 | The dynamic stability has been determinedafter the testing according to the ISO 7176-2,and test results meet it's design specification. | The dynamic stability has been determinedafter the testing according to the ISO 7176-2,and test results meet it's design specification. | The dynamic stability has been determinedafter the testing according to the ISO 7176-2,and test results meet it's design specification. | SE |
| ISO7176-3 | The effectiveness of brakes has beendetermined after the testing according to the | The effectiveness of brakes has beendetermined after the testing according to the | The effectiveness of brakes has beendetermined after the testing according to the | SE |
| ISO 7176-3, and test results meet it's design specification. | ISO 7176-3, and test results meet it's design specification. | ISO 7176-3, and test results meet it's design specification. | ||
| ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet it's design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet it's design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet it's design specification. | SE |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | SE |
| ISO7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | The dimensions, mass has been determined after the testing according to the ISO 7176-5, | SE |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7, | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7, | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7, | SE |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | SE |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | SE |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | SE |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | SE |
| ISO7176-14 | All test results meet the requirements inClause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 ofISO 7176-14 | All test results meet the requirements inClause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 ofISO 7176-14 | All test results meet the requirements inClause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 ofISO 7176-14 | SE |
| ISO7176-15 | The test results shown that informationdisclosure, documentation and labelling ofdevice meet the requirements of ISO 7176-15 | The test results shown that informationdisclosure, documentation and labelling ofdevice meet the requirements of ISO 7176-15 | The test results shown that informationdisclosure, documentation and labelling ofdevice meet the requirements of ISO 7176-15 | SE |
| ISO7176-16 | The performance of resistance to ignitionmeet the requirements of ISO 7176-16 | The performance of resistance to ignitionmeet the requirements of ISO 7176-16 | The performance of resistance to ignitionmeet the requirements of ISO 7176-16 | |
| ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | SE |
| ISO7176-25 | The performance of batteries and charger ofdevice meet the Requirements in Clause 5and 6 of ISO 7176-25 | The performance of batteries and charger ofdevice meet the Requirements in Clause 5 and6 of ISO 7176-25 | The performance of batteries and charger ofdevice meet the Requirements in Clause 5and 6 of ISO 7176-25 | SE |
{10}------------------------------------------------
{11}------------------------------------------------
I. Conclusion
Based on the comparison and analysis above, the is determined to be Substantially Equivalent (SE) to the predicate devices, K. (8247) Scover (KPL001), TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD and K172440 Scooter, Dongguan Prestige Sporting Goods Co., Ltd..
§ 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).