(58 days)
Not Found
No
The description focuses on mechanical and electrical components and control is entirely manual. There is no mention of AI/ML terms or functionalities.
No.
The device is strictly for transportation and mobility assistance; it does not claim to treat or diagnose any medical condition, only to assist with a limitation.
No
The device description and intended use clearly state that it is a mobility scooter designed to provide transportation for disabled or elderly individuals, not to diagnose medical conditions.
No
The device description clearly outlines a physical mobility scooter with a steel frame, wheels, seat, motor, batteries, and brakes. It is a hardware device with some electrical components for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Mobility Scooter Function: The description clearly states the mobility scooter's intended use is to provide mobility to disabled or elderly individuals. It is a physical transportation aid.
- Lack of Biological Specimen Analysis: There is no mention of the device interacting with or analyzing any biological specimens from a human body.
The device described is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The mobility Scoter is a motor driven, indoor 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 Mobility Scooter, Model S1 SPORT, S1 PLUS, MAX SPORT, has a base with Steel frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid Batteries 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 controller panel shape is slightly different among the three models, S1 SPORT, S1 PLUS, MAX SPORT. The S1 PLUS has a wind board on the triller, while the other two models do not have. The length of model MAX SPORT is 5cm longer than the other two models.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization
- . ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes .
- . ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- . ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- . ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- . ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strength
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- . ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- . ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- . ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- . ISO 7176-16: 2012 Second edition 2012-12-01 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
- . ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25:2013 Wheelchairs - Batteries and charqers for powered wheelchairs
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
July 19, 2023
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K231472
Trade/Device Name: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 22, 2023 Received: May 22, 2023
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/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.
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 L. Dean -S
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) K231472
Device Name Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
Indications for Use (Describe)
The mobility Scoter is a motor driven, indoor 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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3
510(k) Summary
l. Applicant
Name: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Address: No. 68 Xinfa Road, Suzhou Industrial Park, Suzhou, Jiangsu, China Name of contact person: Chen Lezhang Telephone: +86 139 1626 7666 Email: lezhang@sweetrich.cn; gc@sweetrich.cn Date prepared: 2023-05-18 Submission Correspondent ll.
Ms. Ivy Wang
Email: zxfda@sungoglobal.com
Shanghai Sungo Management Consulting Company Limited Tel: +86-21-5881 7802
III. Device Device trade name: Mobility Scooter Model: SI SPORT, SI PLUS, MAX SPORT Regulatory Information: Classification name: Vehicle, motorized 3-wheeled Regulation class: 2 Regulation number: 21CFR 890.3800 Panel: Physical Medicine Product code: INI IV. Predicate device
K182471 Device Name: Scooter Model: KPL001 Tianjin Kepler Vehicle Industry Co. Ltd.
V. Device description
4
The Mobility Scooter, Model S1 SPORT, S1 PLUS, MAX SPORT, has a base with Steel frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-ac id Batteries 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 controller panel shape is slightly different among the three models, S1 SPORT, S1 PLUS, MAX SPORT. The S1 PLUS has a wind board on the triller, while the other two models do not have. The length of model MAX SPORT is 5cm longer than the other two models.
VI. Indication for use
The mobility scooter 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.
VII. 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:
- . ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization
- . ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes .
- . ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs
5
and scooters for determination of theoretical distance range
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- . ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- . ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- . ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strength
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- . ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- . ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- . ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- . ISO 7176-16: 2012 Second edition 2012-12-01 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
- . ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25:2013 Wheelchairs - Batteries and charqers for powered wheelchairs
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
VIII. Comparison with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Attribute | Subject device | Predicate device | Results |
| Manufacturer | Suzhou Sweetrich Vehicle | ||
| Industry Technology Co., | |||
| Ltd. | Tianjin Kepler Vehicle | ||
| Industry Co. Ltd. | / | ||
| Proprietary name, | |||
| model | Electrical Scooter | ||
| SI SPORT, SI PLUS, MAX | |||
| SPORT | Scooter, KPL001 | / | |
| 510(k) number | K231472 | K182471 | / |
| Device classification | |||
| name | Class II | Class II | Same |
| Classification | |||
| regulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Product code | INI | INI | Same |
| Similarities | |||
| Indication 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. | Same | ||
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front | ||
| wheels and two rear | |||
| wheels | 4, including two pivoting | ||
| casters and two rear drive | |||
| wheels | Same | ||
| Driving system | Direct drive on the rear | ||
| wheels | Direct drive on the rear | ||
| wheels | Same | ||
| Brake | Electromagnetic | Electromagnetic | Same |
| Time to brake |