(79 days)
Not Found
No
The provided document describes a mobility scooter, which is a motor-driven transportation vehicle. There is no mention of AI models, machine learning, or deep neural networks in the "Mentions AI, DNN, or ML" section, nor in the device description or performance studies.
Yes
The device is intended to provide mobility to disabled or elderly persons, which qualifies as a therapeutic purpose. The extensive list of ISO standards it complies with, many of which are specifically for wheelchairs and medical electrical equipment (e.g., ISO 7176 series, IEC 60601-1-2), further supports its classification as a therapeutic device.
No
The device is described as a mobility scooter designed for transportation and providing mobility to disabled or elderly individuals; it does not mention any function for diagnosing medical conditions.
No
The device is a physical mobility scooter with multiple hardware components such as a frame, motor, wheels, battery, and various control panel elements. The description clearly details these hardware aspects and the extensive list of ISO standards it complies with are primarily for the mechanical and electrical performance of a physical device, not just software.
No.
The device is a mobility scooter which is an assistive device for transportation, not a device intended for in vitro diagnostic examination of specimens derived from the human body.
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
RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle.
It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support.
For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.
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)
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 10993-1: 2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered 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 and scooters for determination of theoretical distance range
- ISO 7176-5:2008, 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 electrically powered 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 fatigue strengths
- 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 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.
The design and technological characteristics of the proposed device scooter is similar to the predicate device. There are minor differences between the devices in frame material, size, load capacity, weight, ground clearance, turn radius, drive system, battery type, charger, controller, motor output, max speed, max slope, travel distance, Distance between Armrests, brake distance and time to brake. All of the parameters with differences have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Scooter is substantially equivalent (SE) to The Scooter (K240008).
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).
FDA 510(k) Clearance Letter - Magnesium Alloy Scooter (RS100)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 14, 2025
Taizhou Reach Technology Co., Ltd
℅ Luna Hu
Official Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, China
Re: K250533
Trade/Device Name: Magnesium alloy scooter (RS100)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: February 24, 2025
Received: February 24, 2025
Dear Luna Hu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K250533 - Luna Hu Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250533 - Luna Hu Page 3
Sincerely,
Tushar Bansal -S
for 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250533
Device Name
Magnesium alloy scooter (RS100)
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)
☒ 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."
Page 5
Taizhou Reach Technology Co., Ltd 510(k) Summary
510(k) number: K250533
Document Prepared Date: 2025/05/14
1. Applicant
Company name: Taizhou Reach Technology Co., Ltd
Address: No.18 Xiangrong Road, Chengqu Industrial Zone, Taixing City, Jiangsu, China
Contact Person: Mr. Fan Rong
Tel: +8618852636388
Submission Correspondent:
Primary Contact: Luna Hu
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-58817802
Email: liu.hu@sungoglobal.com
Secondary Contact: Raymond Luo
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-68828050
Email: zxfda@sungoglobal.com
2. Device
Trade name: Magnesium alloy scooter (RS100)
Classification name: Motorized three-wheeled vehicle
Regulatory Information
Classification: Class II
Product code: INI
Regulation Number: 890.3800
Review Panel: Physical Medicine
3. Predicate Device
Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Product Name: Scooter (W3331)
510(K) #: K240008
Page 6
4. 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.
5. Device Description
RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle.
It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support.
For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.
6. 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 10993-1: 2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered 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 and scooters for determination of theoretical distance range
- ISO 7176-5:2008, 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 electrically powered 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 fatigue strengths
- ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for electric wheelchairs
Page 7
- 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 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
7. Clinical Test Conclusion
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.
8. Comparison technological characteristics with the predicate device
Table 1 General Comparison
| Elements of Comparison | Subject Device | Predicate Device (K240008) | Remark |
|---|---|---|---|
| Manufacturer | Taizhou Reach Technology Co., Ltd | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. | -- |
| Device name | Magnesium alloy scooter | Scooter | -- |
| Model(s) | RS100 | W3331 | -- |
| 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 |
| Overall dimension (mm) | 1130×550×840 | 1110 x 560 x 840 | Similar |
| Frame Material | Magnesium alloy | Steel | Different |
| Front wheel diameter | 200mm × 60mm | 196mm × 66mm | Similar |
Page 8
| Elements of Comparison | Subject Device | Predicate Device (K240008) | Remark |
|---|---|---|---|
| Front Wheels Quantity | 1 | 1 | Same |
| Rear wheel diameter | 8inch × 2inch | 196mm × 66mm | Similar |
| Rear Wheels Quantity | 2 | 2 | Same |
| Ground clearance | 80mm | 35mm | Different |
| Max Loading(on level ground) | 125KG | 120KG | Similar |
| Turn Radius | 1212.5mm | 925mm | Different |
| Motor output | 24 V 150W | LINIX 24 V 180W | Different |
| Drive System | Front Wheel Drive | Rear Wheel Drive | Different |
| Brakes | Electromagnetic brake | Electromagnetic brake | Same |
| Battery | Li-ion battery 25.2V, 20Ah | Lead-acid 12V12Ah*2 | Different |
| Charger | 24V, 3A | 24V, 2A | Different |
| Max Speed | 7.56km/h | 6.83km/h | Different |
| Max Slope | 10° | Dynamic Stability: 6° Static Stability: 8° | Different |
| Travel Distance | 25.3km | 15km | Different |
| Distance between armrests | 42cm | 37-50.5 cm | Different |
| Controller | M3-YG8 | British PG 45A | Different |
| Time to brake |