(780 days)
Not Found
No
The device description and performance studies focus on standard mechanical and electrical components and safety standards for mobility devices, with no mention of AI or ML.
No
The device is described as an indoor and outdoor transportation vehicle to provide mobility to disabled or elderly individuals, not to treat or diagnose certain medical conditions.
No
The device is an electric scooter intended for transportation and mobility, not for diagnosis of any medical condition.
No
The device description clearly outlines numerous physical components (tires, frame, seat, batteries, etc.) and describes it as a "motor driven, indoor and outdoor transportation vehicle," indicating it is a hardware device with some electrical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical aid for transportation, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a physical vehicle with components like tires, a seat, a control panel, and batteries. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing blood, urine, tissue, or any other biological material. There is no mention of reagents, assays, or diagnostic procedures.
- Performance Studies: The listed performance studies are related to the physical characteristics, safety, and biocompatibility of a mobility device (e.g., ISO 7176 standards for wheelchairs and scooters), not the analytical or clinical performance of a diagnostic test.
In summary, the Solax Electric Scooter is a mobility device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes
INI
Device Description
The 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 cytotoxicity
- ISO 10993-10: 2009, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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
1
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
2
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)
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 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 |
|---|---|
| ------------- | ------------------------ |
4
| 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 Scooter |
| Model: 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.
5
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
6
- 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
7
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 of
| Comparison | Predicate Device | Subject Device | Remark |
|---|---|---|---|
| Proprietary | |||
| name | Solax Electric Scooter | Solax Electric Scooter | -- |
| Model | S302121, S302131, S302141, | ||
| S302151 | S204311M, S204161, S204143 | -- | |
| 510K Number | K172440 | K190737 | -- |
| Common or | |||
| Usual name | Electrical scooter | Electrical scooter | -- |
| Intended use | It is a motor driven, indoor and | ||
| outdoor transportation vehicle with | |||
| the intended use to provide mobility | |||
| to a disabled or elderly person | |||
| limited to a seated position. | It is a motor driven, indoor and | ||
| outdoor transportation vehicle with | |||
| the intended use to provide mobility | |||
| to a disabled or elderly person | |||
| limited to a seated position. | SE | ||
| 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. | 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. | SE | ||
| Rx or OTC? | OTC | OTC | SE |
| Size (unfold) | 930450865mm | S204311M: 980450940mm | |
| S204161: 930450860mm | SE | ||
| Note 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° | SE | ||
| Note 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) | SE | ||
| Note 1 | |||
| Base weight(not including battery) | 24 kg | S204311M: 24kg | |
| S204161, S204143: 24.7 kg | SE | ||
| Note 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. | SE |
| Note 1 | |||
| Ground clearance | 36 mm | S204311M: 38mm | |
| S204161, S204143: 58mm | SE | ||
| Note 1 | |||
| Obstacle Climbing Ability | 38 mm | S204311M: 40mm | |
| S204161, S204143: 60mm | SE | ||
| Note 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 | SE | ||
| Note 2 | |||
| Remote | |||
| control | None | Yes | SE |
| Note 2 | |||
| Battery | Lithium battery | ||
| 24V/10AH | Lithium battery | ||
| 24V/10AH | SE | ||
| Motor | 24V 120W | 24V 120W | SE |
| Battery | |||
| charger | DC24V/2A | DC24V/2A | SE |
| Biocompatibility | All user directly contacting materials | ||
| are compliance with ISO10993-5 | |||
| and ISO10993-10 requirements. | All user directly contacting materials | ||
| are compliance with ISO10993-5 | |||
| and ISO10993-10 requirements. | SE |
8
9
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.