(336 days)
Not Found
No
The description focuses on standard mechanical and electrical components and control mechanisms operated directly by the user. There is no mention of AI, ML, image processing, or data-driven decision-making.
No.
The device is a transportation vehicle designed to provide mobility for disabled or elderly individuals, not to treat or diagnose a medical condition.
No
The device is described as an "indoor and outdoor transportation vehicle" intended to "provide mobility to a disabled or elderly person." Its function is for transportation, not for diagnosing any medical condition. The listed performance studies focus on the physical and electrical characteristics of a mobility device, not diagnostic capabilities.
No
The device description clearly outlines numerous hardware components including a frame, wheels, seat, motor, brake, battery, and remote. The performance studies also focus on physical characteristics and safety of a hardware device.
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 function, not a diagnostic one.
- Device Description: The description details a transportation vehicle with mechanical and electrical components for movement. It does not mention any components or functions related to testing biological samples or providing diagnostic information.
- Performance Studies: The listed performance studies are related to the physical characteristics, safety, and functionality of a mobility device (wheelchair/scooter standards). They do not include any studies related to diagnostic accuracy or performance.
- Biocompatibility Standards: While the device conforms to biocompatibility standards (ISO 10993), this is a common requirement for medical devices that come into contact with the body, not specifically for IVDs.
- No Mention of Diagnostic Function: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
In vitro diagnostics (IVDs) are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device clearly falls outside of that definition.
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 (comma separated list FDA assigned to the subject device)
INI
Device Description
The Solax Electric Scooter (Models: S302121, S302131, S302141, S302151) 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 aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a remote for folding/unfolding the device and a Lithium battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the 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
disabled or elderly person
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 and safety tests were conducted with Solax Electric Scooter:
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
- ISO 7176-2:2001, 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: 2001, 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 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 3.0, 2010
- 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2018
Dongguan Prestige Sporting Goods Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510663 CN
Re: K172440
Trade/Device Name: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: April 29, 2018 Received: May 3, 2018
Dear Cassie Lee:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172440
Device Name
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
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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3
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter'sInformation
- � 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 �
Application Correspondent: 2.
- � Contact Person: Ms. Cassie Lee
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- � Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China
- Tel:+86-20-61099984 �
- � Email: regulatory@glomed-info.com
3. Subject Device Information
| Trade Name: | Solax Electric Scooter
Model: S302121, S302131, S302141, S302151 |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Scooter |
| Classification name: | Vehicle, Motorized 3-Wheeled |
| Review Panel: | Physical Medicine |
| Product Code: | INI |
| Regulation Class: | 2 |
| Regulation Number: | 890.3800 |
Predicate Device Information 4.
| Sponsor | Dongguan Prestige Sporting Goods Co., Ltd. |
|---|---|
| Device Name | MOBIE scooter |
4
| 510(k) Number | K122749 |
|---|---|
| Product Code | INI |
| Regulation Number | 890.3800 |
| Regulation Class | 2 |
5. DeviceDescription
The Solax Electric Scooter (Models: S302121, S302131, S302141, S302151) 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 aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a remote for folding/unfolding the device and a Lithium battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the 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
lt 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. Tests Summary
The following performance and safety tests were conducted with Solax Electric Scooter:
- ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
- ISO 7176-2:2001, 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: 2001, 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
5
- 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 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 3.0, 2010
- · 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
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 | MOBIE scooter | Solax Electric Scooter | -- |
| Model | Mobie | S302121, S302131, S302141, | |
| S302151 | -- | ||
| 510K Number | K122749 | K172440 | -- |
| Common or | |||
| Usual name | Electrical scooter | Electrical scooter | -- |
6
| 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 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Size (unfold) | 980450985mm | 930450865mm | SE
Note |
| 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
Note |
| Speed | 6 km/h (3.7mph) | 6 km/h (3.7mph) | SE |
| Safe Gradient /
Maximum
Gradient | 0-13° | 0-12° | SE
Note |
| Range | 15 km (9.32mile) | 15 km (9.32mile) | SE |
| Turning circle | 1.4 m | 1.55 m | SE
note |
| Base
weight(not
including
battery) | 25 kg | 24 kg | SE
Note |
| 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 | 136 kg Approx. | 125 kg Approx. | SE
Note |
| Ground
clearance | 36 mm | 36 mm | SE |
| Obstacle
Climbing Ability | 38 mm | 38 mm | SE |
| 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 |
| EMC | ISO 7176 - 21 | ISO 7176 - 21 | SE |
| Performance | ISO 7176 series | ISO 7176 series | SE |
Comparison in Detail(s):
Note :
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, Turning circle, Maximum capacity, Ground clearance, Battery and motor. There is no deleterious effect on safety and effectiveness due to 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
7
raise any questions as to the safety and effectiveness. Therefore, the Solax Electric Scooter is substantially equivalent to the MOBIE (K122749).