(780 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 Solax Electric Scooter (Models: S204311M, S204161, S204143) 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 the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr. The movement of the scooter is controlled by the steering handles and control panel. 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.
This FDA 510(k) summary (K190737) describes the substantial equivalence of the Solax Electric Scooter to a previously cleared predicate device, rather than providing details of a study akin to those conducted for AI/ML-based medical devices. Therefore, much of the requested information regarding acceptance criteria, human reader studies, and ground truth establishment for AI systems is not applicable or present in this document.
However, I can extract information related to the performance testing and comparison to the predicate device, framing it as acceptance criteria and proof of meeting them within the context of a non-AI medical device.
Device Name: Solax Electric Scooter (Models: S204311M, S204161, S204143)
Intended Use: 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.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like this electric scooter, "acceptance criteria" are typically defined by performance standards (e.g., ISO standards) and by demonstrating equivalence to a predicate device. The "reported device performance" is the successful compliance with these standards and the demonstration that any differences from the predicate do not raise new safety or effectiveness concerns.
| Acceptance Criteria Category (Derived from Standards & Predicate Comparison) | Specific Criterion (Standard / Predicate Characteristic) | Reported Device Performance (Subject Device Characteristic) | Meets Criteria? |
|---|---|---|---|
| General Characteristics (Equivalence to Predicate) | Same Intended Use as Predicate (K172440) | 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. | Yes |
| Same Indications for Use as Predicate | 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. | Yes | |
| OTC Use as Predicate | OTC | Yes | |
| Similar Tires (6 inches front, 7 inches rear, solid) | 6 inches for front wheel (solid wheel), 7 inches for rear wheel (solid wheel) | Yes | |
| Same Speed (6 km/h / 3.7 mph) | 6 km/h (3.7mph) | Yes | |
| Same Range (15 km / 9.32 mile) | 15 km (9.32mile) | Yes | |
| Same Battery Weight (1.84 kg) | 1.84 kg | Yes | |
| Same Brake Type (Electromagnetic) | Electromagnetic | Yes | |
| Same Drive System (PG 45A / Rear wheel drive) | PG 45A / Rear wheel drive | Yes | |
| Same Battery (Lithium battery 24V/10AH) | Lithium battery 24V/10AH | Yes | |
| Same Motor (24V 120W) | 24V 120W | Yes | |
| Same Battery Charger (DC24V/2A) | DC24V/2A | Yes | |
| Same Frame Design/Construction (X type, aluminum alloy) | X type, aluminum alloy frame | Yes | |
| Specific Performance Parameters (Compared to Predicate) | Overall Dimensions: S302121: 930450865mm | S204311M: 980450940mm, S204161: 930450860mm, S204143: 980450880mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) |
| Safe Gradient / Max Gradient: 0-12° | S204311M: 0-13°, S204161, S204143: 0-15° (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Turning Circle: 1.55 m | S204311M: 1.55m, S204161, S204143: 1.35 m (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Base Weight: 24 kg | S204311M: 24kg, S204161, S204143: 24.7 kg (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Maximum Capacity: 125 kg Approx. | 125 kg Approx. (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes | |
| Ground Clearance: 36 mm | S204311M: 38mm, S204161, S204143: 58mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Obstacle Climbing Ability: 38 mm | S204311M: 40mm, S204161, S204143: 60mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Folding Mechanism: Manual folding and remote folding (Predicate) | Manual folding for S204311M, S204161, S204143 (Note 2: Difference will not affect basic safety/indications for use, not a necessary function) | Yes (with justification) | |
| Remote Control: None (Predicate) | Yes (New feature, Note 2: Difference will not affect basic safety/indications for use, not a necessary function) | Yes (with justification) | |
| Safety and Performance Standards Compliance (Demonstrated through Testing) | ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability | Conducted | Yes |
| ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes | Conducted | Yes | |
| ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Conducted | Yes | |
| ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space | Conducted | Yes | |
| ISO 7176-6: 2018, Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-7, First Edition 1998-05-15, Wheelchairs Part 7: Measurement of seating and wheel dimensions | Conducted | Yes | |
| ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths | Conducted | Yes | |
| ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Conducted | Yes | |
| ISO 7176-11, Second edition 2012-12-01, Wheelchairs Part 11: Test dummies | Conducted | Yes | |
| ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient of friction of test surfaces | Conducted | Yes | |
| ISO 7176-14:2008, Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Conducted | Yes | |
| ISO 7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling | Conducted | Yes | |
| ISO 7176-16, Second edition 2012-12-01, Wheelchairs Part 16: Resistance to ignition of postural support devices | Conducted | Yes | |
| ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Conducted | Yes | |
| IEC 62304: 2006 (First Edition), Medical device software, Software life-cycle processes. (Applicable if there's software) | Conducted | Yes | |
| IEC 60601-1-6 Medical electrical equipment- Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.1, 2013 | Conducted | Yes | |
| IEC 62366 Medical devices Application of usability engineering to medical devices Edition 1.0.2007 | Conducted | Yes | |
| Biocompatibility | All user directly contacting materials compliant with ISO10993-5:2009 (Tests for In Vitro cytotoxicity) and ISO10993-10:2009 (Tests for irritation and delayed-type hypersensitivity) | Materials and manufacturing used are identical to predicate device, which demonstrated conformity. Subject device materials confirmed compliant. | Yes |
The remaining numbered points are primarily for AI/ML device studies and are not directly applicable to a traditional device 510(k) submission like this one, which relies on performance testing and substantial equivalence to a predicate.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an AI/ML test set. The study involves testing physical units of the scooter according to various ISO standards. The specific number of units tested is not detailed in this summary but would be determined by the requirements of each standard.
- Data Provenance: Not applicable. The "data" are results from physical performance and biocompatibility testing of the device itself, rather than a dataset of patient information. The testing would have been conducted by the manufacturer or a certified testing lab, likely in China, given the manufacturer's location. The testing is prospective in the sense that it's performed on the manufactured product to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the AI/ML sense (e.g., expert annotation of medical images) is not relevant here. Compliance with ISO standards is determined by prescribed test methods and objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human reader study requiring adjudication. Test results are objectively measured against standard specifications.
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 is not an AI-assisted device or an imaging device requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not use an algorithm in that capacity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the various ISO performance and safety standards, and the direct comparison of its physical and functional characteristics to the predicate device.
8. The sample size for the training set:
- 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:
- 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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2021
Dongguan Prestige Sporting Goods Co., Ltd. Ms. SK Manager SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou. 510663 China
Re: K190737
Trade/Device Name: Solax Electric Scooter (Models: S204311M, S204161, S204143) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: February 3, 2021 Received: February 9, 2021
Dear Ms. SK:
We have reviewed vour 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 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
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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 mediation-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 Injurv 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
Enclosure
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Indications for Use
510(k) Number (if known) K190737
Device Name
Solax Electric Scooter (Models: S204311M, S204161, S204143)
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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510(k) Summary for K190737
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Dongguan Prestige Sporting Goods Co., Ltd. �
- � Establishment Registration Number: 3008841035
- Address: 3rd industrial ,Qiaotou Area, Houjie Town, Dongguan City, Guangdong province, �
China
- � Tel: 13763128800
- � Fax: 86-769-85922505
- � Contact Person: Zhang Zhao (General Manager)
- � E-mail: leon@wisefame.com
2. Application Correspondent:
- � Contact Person: Ms. SK
- � SK Medical Device International Corp.
- � Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou,
Guangdong, China
- � Tel: +86-18620793542
- � Email: medical-device@qq.com
3. Subject Device Information
| Trade Name: | Solax Electric Scooter |
|---|---|
| ------------- | ------------------------ |
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| Model: S204311M, S204161, S204143 | |
|---|---|
| Common Name: | Scooter |
| Classification name: | Vehicle, Motorized 3-Wheeled |
| Review Panel: | Physical Medicine |
| Product Code: | INI |
| Regulation Class: | 2 |
| Regulation Number: | 890.3800 |
| 4. Predicate Device Information | ||
|---|---|---|
| Sponsor | Dongguan Prestige Sporting Goods Co., Ltd. |
|---|---|
| Device Name | Solax Electric ScooterModel: S302121, S302131, S302141, S302151 |
| Common Name: | Scooter |
| Classification name: | Vehicle, Motorized 3-Wheeled |
| Review Panel: | Physical Medicine |
| 510(k) Number | K172440 |
| Product Code | INI |
| Regulation Number | 890.3800 |
| Regulation Class | 2 |
5. Device Description
The Solax Electric Scooter (Models: S204311M, S204161, S204143) 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 the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr.
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The movement of the scooter is controlled by the steering handles and control panel. 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.
6. 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.
7. Performance Summary
The following performance, safety and biocompatibility tests were conducted with Solax Electric Scooter:
- · ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
- 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, First Edition 1998-05-15, 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
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- 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, Second edition 2012-12-01, Wheelchairs Part 11: Test dummies
- · ISO 7176-13, First edition 1989-08-01, 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 methods
- · ISO 7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling
- · ISO 7176-16, Second edition 2012-12-01, Wheelchairs Part 16: Resistance to ignition of postural support devices
- ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- · IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
- · IEC 60601-1-6 Medical electrical equipment- Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.1, 2013
- · IEC 62366 Medical devices Application of usability engineering to medical devices Edition 1.0.2007
The materials and manufacturing used for the Solax Electric Scooter are identical to those of the predicate device, which were demonstrated to conform with the following biocompatibility standards:
- · ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for In Vitro
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cytotoxicity
- ISO 10993-10: 2009, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Solax Electric Scooter is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Predicate Device | Subject Device | Remark |
|---|---|---|---|
| Proprietaryname | Solax Electric Scooter | Solax Electric Scooter | -- |
| Model | S302121, S302131, S302141,S302151 | S204311M, S204161, S204143 | -- |
| 510K Number | K172440 | K190737 | -- |
| Common orUsual name | Electrical scooter | Electrical scooter | -- |
| Intended use | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly personlimited to a seated position. | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly personlimited to a seated position. | SE |
| Indicationsfor use | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly personlimited to a seated position. | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly personlimited to a seated position. | SE |
| Rx or OTC? | OTC | OTC | SE |
| Size (unfold) | 930450865mm | S204311M: 980450940mmS204161: 930450860mm | SENote 1 |
| S204143: 980450880mm | |||
| Tires | 6 inches for front wheel (solid wheel)7 inches for rear wheel (solid wheel) | 6 inches for front wheel (solid wheel)7 inches for rear wheel (solid wheel) | SE |
| Speed | 6 km/h (3.7mph) | 6 km/h (3.7mph) | SE |
| Safe Gradient / Maximum Gradient | 0-12° | S204311M: 0-13°S204161, S204143: 0-15° | SENote 1 |
| Range | 15 km (9.32mile) | 15 km (9.32mile) | SE |
| Turning circle | 1.55 m | S204311M: 1.55m (with a speed less than 3km/h is recommend)S204161, S204143: 1.35 m (with a speed less than 3km/h is recommend) | SENote 1 |
| Base weight(not including battery) | 24 kg | S204311M: 24kgS204161, S204143: 24.7 kg | SENote 1 |
| Battery weight | 1.84 kg | 1.84 kg | SE |
| Brake | Electromagnetic | Electromagnetic | SE |
| Drive system | PG 45A / Rear wheel drive | PG 45A / Rear wheel drive | SE |
| Maximum capacity | 125 kg Approx. | 125 kg Approx. | SENote 1 |
| Ground clearance | 36 mm | S204311M: 38mmS204161, S204143: 58mm | SENote 1 |
| Obstacle Climbing Ability | 38 mm | S204311M: 40mmS204161, S204143: 60mm | SENote 1 |
| Frame design - Construction | X type | X type | SE |
| Frame design - Materials | aluminum alloy frame | aluminum alloy frame | SE |
| Folding mechanism | Manual folding and remote folding | Manual folding for S204311M,S204161, S204143 | SENote 2 |
| Remotecontrol | None | Yes | SENote 2 |
| Battery | Lithium battery24V/10AH | Lithium battery24V/10AH | SE |
| Motor | 24V 120W | 24V 120W | SE |
| Batterycharger | DC24V/2A | DC24V/2A | SE |
| Biocompatibility | All user directly contacting materialsare compliance with ISO10993-5and ISO10993-10 requirements. | All user directly contacting materialsare compliance with ISO10993-5and ISO10993-10 requirements. | SE |
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K190737
Comparison in Detail(s):
Note 1:
The design and technological characteristics of the Solax Electric Scooter is basically similar to the predicate device chosen. There are minor differences between the devices including overall dimensions, Safe Gradient, Base weight, Maximum capacity, Ground clearance, Obstacle Climbing Ability. There is no deleterious affection of safety and effectiveness about the differences and these minor differences do not influence 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. Therefore the Solax Electric Scooter (models: S204311M, S204143) is substantially equivalent to the Solax Electric Scooter (models: S302121, S302141, S302151) (K172440).
Note 2:
Although the "Folding mechanism" and "Remote control" is a little different with - predicate device,
but these difference will not affect the basic safety and indications for use of subject device, they
are not necessary function which will not raise any safety issue and effectiveness issue.
9. Date of the summary prepared: May 6, 2021
§ 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).