Mobility Scooter (Air Carbon)
Device Facts
| Record ID | K260717 |
|---|---|
| Device Name | Mobility Scooter (Air Carbon) |
| Applicant | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
| Product Code | INI · Physical Medicine |
| Decision Date | May 20, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3800 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Motorized four-wheeled mobility scooter; carbon fiber frame; ABS body shell; user-operated via control panel and direction handles; electromagnetic braking system; powered by rechargeable Li-ion battery; foldable design for transport. Intended for indoor/outdoor use by disabled or elderly individuals. Provides mobility; enhances independence. Performance validated via bench testing per ISO 7176 series.
Clinical Evidence
No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including static/dynamic stability, brake effectiveness, energy consumption, obstacle climbing, and electromagnetic compatibility (ISO 7176 series and IEC 60601-1-2).
Technological Characteristics
Carbon fiber frame; ABS body shell; PU solid tires; electromagnetic brake; 24V brushless motor; 24V 6.4Ah Li-ion battery; DC 24V/2A charger. Complies with ISO 7176 series (stability, strength, energy, EMC) and ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility assistance.
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 (Air Classic, Air Traveller, Air Traveller2.0) (K253075)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 20, 2026
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
% Andrew Wang
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai, Shanghai 200122
China
Re: K260717
Trade/Device Name: Mobility Scooter (Air Carbon)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: March 5, 2026
Received: March 5, 2026
Dear Andrew 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 (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
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K260717 - Andrew Wang
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(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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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).
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K260717 - Andrew Wang
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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
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| 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. |
| --- | --- |
| 510(k) Number (if known) K260717 | |
| Device Name Mobility Scooter (Air Carbon) | |
| Indications for Use (Describe) 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. | |
| 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." | |
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Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
# 510(k) Summary
Document Prepared Date: 2026-05-14
## 1. Applicant Information
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Address: Building B, No.7 Chao Qian Road, Suzhou Industrial Park, Suzhou, Jiangsu Province, China
Contact: Mr. Chen Lezhang
Tel: +86 139 1626 7666
Email: lezhang@sweetrich.cn; qc@sweetrich.cn
Submission Correspondent:
Primary Contact: Andrew Wang
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-58817802
Email: yuanju.wang@sungoglobal.com
## 2. Subject Device
Device Name: Mobility Scooter
Model: Air Carbon
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
## 3. Predicate Device
Mobility Scooter (Air Classic, Air Traveller, Air Traveller2.0), K253075
## 4. Device Description
The Mobility Scooter (Air Carbon) features a base with a carbon fiber frame and an ABS body shell. It comes equipped with two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, motor, an electromagnetic brake, and rechargeable Li-ion battery pack with an off-board charger. The movement of the scooter is controlled by control panel and direction handles.
The device is installed with an electromagnetic brake. And the device can be folded. The maximum load capacity is 120KG.
## 5. Indication for Use
This mobility scooter is a motor driven, indoor and outdoor transportation vehicle with the intended use to
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provide mobility to a disabled or elderly person limited to a seated position.
## 6. Product parameters
| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Manufacturer | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | / |
| Proprietary name, model | Mobility Scooter Air Carbon | Mobility Scooter Air Classic, Air Traveller, Air Traveller2.0 | / |
| 510(k) number | K260717 | K253075 | / |
| 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 |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear wheels | Air Classic: 3, including one front wheels and two rear wheels Air Traveller&Air Traveller2.0: 4, including two front wheels and two rear wheels | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake | Electromagnetic | Electromagnetic | Same |
| Time to brake | < 1 s | < 1 s | Same |
| Brake distance | 1.64m | <1m | Same |
| Frame style | Foldable seat, removable battery pack, disassemble for transport | Foldable seat, removable battery pack, disassemble for transport | Same |
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| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Battery | Li-ion Battery Pack 24V 6.4Ah | Llithium-ion battery 24V/12AH | 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. |
| Max loading weight | 120 kg/265 lbs approx | 120 kg/265 lbs approx | Same |
| Max speed | 1.73m/s (6.2km/h) | Air Classic:1.73m/s(6.2km/h) Air Traveller&Air Traveller2.0: 1.78m/s(6.4 km/h) | Same |
| Charger | DC 24V/2A | DC 24V/2A | Same |
| Main frame material | Carbon fiber | Aluminium | Different material used for frame, that such difference will not impact the safety and effectiveness of the subject device as the performance tests are conducted according to ISO 7176 series. |
| Front wheel size/type | PU Solid tire, 7inch (=177.8mm) | Air Classic: 150*38mm ,PU Solid tire Air Traveller&Air Traveller2.0: 178*48mm, PU Solid tire | Minor difference on wheel size will not cause new safety and effectiveness concerns raised. |
| Rear wheel size/type | PU Solid tire, 8inch (=203.2mm) | Air Classic: 190*50 PU Solid tire Air Traveller&Air Traveller2.0: 188*48mm PU Solid tire | |
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| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Overall Dimension (length*width*height) | 1030*517*920mm | Air Classic:1115*505*881mm Air Traveller&Air Traveller2.0: 1193*495*858mm | Minor difference on scooter dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Maximum distance of travel on the fully charged battery | 11.7km | Air Classic:16km Air Traveller&Air Traveller2.0: 18.1km | Minor difference on travel distance will not cause new safety and effectiveness concerns raised. |
| Turning Radius | 1375mm | Air Classic:1035mm Air Traveller&Air Traveller2.0: 1600mm | Minor difference on turning radius will not cause new safety and effectiveness concerns raised. |
| Ground clearance | 34mm | Air Classic:19mm Air Traveller&Air Traveller2.0: 59mm | Minor difference on ground clearance will not cause new safety and effectiveness concerns raised. |
| Maximum obstacle climbing | 30mm | Air Classic:20mm Air Traveller&Air Traveller2.0: 15mm | The difference on maximum obstacle climbing will not cause new safety and effectiveness concerns raised. |
| Slope grade ability | 8° | 10° | Minor difference on slope grade ability will not cause different performance. No safety or effectiveness concerns raised. |
| Controller | 24V30A/180W-300W | 24V32A,180W-300W | Both meet the requirements of the ISO 7176-14. Not cause new safety and effectiveness concerns raised. |
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| Attribute | Subject device | Predicate device | Results |
| --- | --- | --- | --- |
| Motor | Brushless motor, 24V180W | Air Classic: Brushless motor,24V/250W Air Traveller&Air Traveller2.0: Brushless motor,24V/180W | Same |
| Base weight (not including battery) | 14.16kg | Air Classic:25.47kg Air Traveller&Air Traveller2.0: 22.46kg | Minor difference on scooter weight will not cause different performance. No safety or effectiveness concerns raised. |
## Substantial Equivalence Discussion:
The mobility scooter complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2:2020, ISO 10993-1. The intended uses for both devices are the same. The frame style of the two devices are both foldable seat, removable battery pack and disassemble for transport. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Those dimension difference will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO10993-1. In conclusion, the technological characteristics, features, specifications, mode of operation, and intended use of the device 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.
## 7. Product Performance
### 7.1 Product Material Safety
| Item | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| 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 |
### 7.2 Performance of the products
The following performance data were provided to verify that the subject device met all design
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specifications and provided support of the substantial equivalence determination.
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 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 fatigue
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 7176-14:2022 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 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
ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
| Item | Proposed 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 |
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| Item | Proposed Device | Predicate Device | Results |
| --- | --- | --- | --- |
| 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 |
| 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 |
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| Item | Proposed Device | Predicate Device | Results |
| --- | --- | --- | --- |
| 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 |
| ISO7176-16/ 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 7176-25 | 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 |
## 8. 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.
## 9. Conclusion
The current device and the predicate devices have the same technological characteristics, features, specifications, mode of operation, and intended use of the device. To ensure all the key characteristic of the products can meet the requirements, testing was done and all the results indicate the positive conclusion. Based on the analysis above, we confirm these two devices are substantially equivalent.
