Mobility Scooter (CL-Q3, CL-Q4)
Device Facts
| Record ID | K253631 |
|---|---|
| Device Name | Mobility Scooter (CL-Q3, CL-Q4) |
| Applicant | Zhejiang Wei Ling New Energy Technology Co., Ltd. |
| Product Code | INI · Physical Medicine |
| Decision Date | Feb 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3800 |
| Device Class | Class 2 |
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.
Device Story
Motor-driven, three-wheeled mobility scooter; provides mobility for disabled or elderly persons in seated position. Rider operates via tiller console, throttle lever, speed control dial, and handle. Features electric motor, electromagnetic brake (automatic engagement when not in use), rechargeable battery, and key switch. Used indoors and on paved outdoor surfaces. Output is physical transport of user. Benefits include increased mobility and independence for users with limited walking ability. Device is foldable/disassemblable for transport.
Clinical Evidence
Bench testing only. No clinical or animal studies performed. Substantial equivalence demonstrated through compliance with ISO 7176 series (stability, braking, obstacle climbing, battery, EMC) and IEC 60601-1-2 standards.
Technological Characteristics
Carbon steel frame; electric motor; electromagnetic braking; rechargeable battery (SLA or Li-ion). Dimensions vary by model (CL-Q3/CL-Q4). Complies with ISO 7176 series (stability, performance, dimensions, battery, EMC) and IEC 60601-1-2. Biocompatibility per ISO 10993-5/10.
Indications for Use
Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility.
Regulatory Classification
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.
Predicate Devices
- Mobility Scooter (K252588)
Related Devices
- K151944 — Luggie Super · Freerider Corporation · Sep 10, 2015
- K070802 — LERADOTECH, MODEL SC · Lerado China Limited · Apr 13, 2007
- K083303 — LANDLEX, MODEL: 402X · Besteam Technology, Inc. · Jan 26, 2009
- K050792 — LANDLEX, MODEL S300X · Cycling and Health Tech. Industry R&D Center · Apr 21, 2005
- K253075 — Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jan 9, 2026
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
February 23, 2026
Zhejiang Wei Ling New Energy Technology Co., Ltd.
% Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,
China
Re: K253631
Trade/Device Name: Mobility Scooter (CL-Q3, CL-Q4)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: November 19, 2025
Received: November 19, 2025
Dear Kiwi Xu:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K253631 - Kiwi Xu
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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).
{2}
K253631 - Kiwi Xu
Page 3
Sincerely,
Tushar Bansal -S
Tushar Bansal, PhD
Acting 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
Enclosure
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253631 | ? |
| Please provide the device trade name(s). | | ? |
| Mobility Scooter (CL-Q3, CL-Q4) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
{4}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
# 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2026.02.02
## Submitter:
Name: Zhejiang Wei Ling New Energy Technology Co.,Ltd.
Address: No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City, Zhejiang Province, China
Contact: Zhe Zhang
Tel: +86 13656586999
E-mail: yirenweiben@126.com
## Device:
510(k) number: K253631
Trade/Device Name: Mobility Scooter
Model: CL-Q3/CL-Q4
Regulation Name: Motorized Three-Wheeled
Vehicle
Regulation Class: II
Regulation Number: 21CFR 890.3800
Panel: Physical Medicine
Product Code: INI
## Predicate device:
510(k) number: K252588
Device Trade Name: Mobility Scooter
Model: T5
Zhejiang Taotao Vehicle Co.,LTD.
## Device description:
This 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.
The Mobility Scooter, has a base with two front wheels, two rear wheels, two support wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable battery with an off-board charger, a key
{5}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
switch. 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 can only be operated on the flat road.
## 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.
## 1. Product Parameters
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Manufacturer | Zhejiang Wei Ling New Energy Technology Co.,Ltd. | Zhejiang Taotao Vehicle Co.,LTD. | / |
| Proprietary name, model | Mobility Scooter, CL-Q3/CL-Q4 | Mobility Scooter, T5 | / |
| 510(k) number | K253631 | K252588 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Product code | INI | INI | Same |
| 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 |
| Rear Wheels Quantity | 2 | 2 | Same |
| Ground clearance | CL-Q3:65mm | 20 mm | Both of the devices are evaluated according to standard ISO 7176-5:2017, so the different will not impact the safety and effectiveness |
| | CL-Q4:60mm | | |
| Operating surface & environment | Indoor use and restricted outdoor use on pavements or paved footpaths only. | Indoor use and restricted outdoor use on pavements or paved footpaths only. | Same |
| Remote control | None | None | Same |
| Total mass | CL-Q3:60 kg
CL-Q4:41 kg | 54 kg | Both of the devices are evaluated according to standard ISO 7176-5, so the different static stability will not impact the safety and effectiveness |
| Brake | Electromagnetic | Electromagnetic | Same |
{6}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Time to brake | < 1 s | < 1 s | Same |
| Max speed | 6 km/h | 7.92 km/h | Both of the devices are evaluated according to standard ISO 7176-6, so the different static stability will not impact the safety and effectiveness |
| Frame style | Foldable seat, removable battery pack, disassemble for transport. | Foldable seat, removable battery pack, disassemble for transport. | Same |
| Battery | CL-Q3:Sealed Lead Acid Battery 12V/20Ah×3 | Lithium battery 25.6Vdc 15Ah | The subject device complies with ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs and EMC testing, these differences do not affect safety and effectiveness. |
| | CL-Q4:Li-ion Battery 36V/15Ah | | |
| Main frame material | Carbon steel | Steel | |
| Max Slope | CL-Q3:10° | 6° | Both of the devices are evaluated according to standard ISO 7176-2:2017, so the different static stability will not impact the safety and effectiveness |
| | CL-Q4: 6° | | |
| Max loading weight | 110 kg | 150 kg | |
| Brake Distance - Normal operation(Horizontal-Forward-Max speed) | CL-Q3:1.2m | ≤1.3m | The subject device complies with ISO 7176-3 testing, the difference do not affect safety and effectiveness. |
| | CL-Q4:1.5m | | |
| Travel Distance | CL-Q3:26.4 km | 18.5km | |
| | CL-Q4:29.5 km | | Minor difference on travel distance will not cause new safety and effectiveness concerns raised. |
| Overall Dimension (length*width*height) | CL-Q3:1060*510* 970mm | 1240mm*610mm*875mm | |
| | CL-Q4:1030*620* 1360mm | | Minor difference on scooter dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Min Turning Radius | CL-Q3:1900 mm | 2175 mm | Minor difference on turning radius will not cause new safety and effectiveness concerns raised. |
| | CL-Q4:2000 mm | | |
| Motor output | CL-Q3:36 VDC 250W | 24 V 350W | Both of the devices are evaluated according to standard ISO 7176-1:2014, minor difference on motor power will not cause safety or effectiveness concerns raised. |
| | CL-Q4:36 VDC, 4.5Amax, 250W, 4100rpm | | |
| Charger | CL-Q3:Input:AC220V-240VOutput:DC44.25V,3.0A | 29.4V/2A | Minor difference on input current will not cause safety or effectiveness concerns raised. |
| | CL-Q4: | | |
{7}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| | Input: AC220V,50/60Hz135WOutput: DC42V,3.0A | | |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | Same |
| Stowage size(length*width*height) | CL-Q3:1060*510*530mm | 600*1240*560mm | Both of the devices are evaluated according to standard ISO 7176 series, so the different size will not impact the safety and effectiveness |
| | CL-Q4:500*6200*630mm | | |
| Front Tire Diameter | CL-Q3:7.87 inch*1.96 inch | 9inch | |
| | CL-Q4:10 inch*2.15 inch | | |
| Rear Tire Diameter | 7.87 inch*1.96 inch | 9inch | |
Table 2 Safety comparison
| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| Biocompatibility | Conforms to FDA Regulatory | All directly tissue-contacting materials are in compliance with ISO10993-5 and ISO10993-10 requirements. | Same |
| Electromagnetic Compatibility (EMC) | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory requirements | Same |
| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | Same |
| ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | Same |
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | Same |
| ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | Same |
{8}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | Same |
| ISO7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | Same |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | Same |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | Same |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | Same |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | Same |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | Same |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | Same |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | Same |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | Same |
| ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | Same |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | Same |
| ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | Same |
{9}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | Same |
# Substantial Equivalence Discussion
The proposed (subject) device and predicate device are complying to the same ISO standards, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21, ISO 7176-
{10}
Zhejiang Wei Ling New Energy Technology Co.,Ltd.
No.12 Jinnan Road, Pubagang Town, Sanmen County, Taizhou City,Zhejiang Province, China
22, ISO 7176-25, and 1995 FDA Guidance on 510(k) Submissions for Mechanical and Mobile scooter. The subject device also provided electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and Enhanced-level software documentation (including verification and validation testing) in accordance with FDA’s 2023 Guidance on the “Content of Premarket Submissions for Device Software Functions.”
The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus substantially equivalent to the predicate device in performance.
The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.
## 3. Summary of clinical testing:
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.
## 4. Substantially Equivalency Conclusion
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device, K252588 Mobility Scooter from Zhejiang Taotao Vehicle Co.,LTD..
