(108 days)
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.
The Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries 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.Seat and handlebar can be folded.The maximum load capacity is 120KG.
N/A
FDA 510(k) Clearance Letter - K253075
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 9, 2026
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
℅ Ariel Xiang
Shanghai Sungo Management Consulting Co. Ltd.
14th Floor, 1500# Century Avenue
Shanghai, Shanghai 200122
China
Re: K253075
Trade/Device Name: mobility scooter (Air Classic); mobility scooter (Air Traveller); mobility scooter (Air Traveller 2.0)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: December 10, 2025
Received: December 10, 2025
Dear Ariel Xiang:
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"
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K253075 - Ariel Xiang 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).
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K253075 - Ariel Xiang 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
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Indications for Use
| Field | Content |
|---|---|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253075 |
| Please provide the device trade name(s). | mobility scooter (Air Classic); mobility scooter (Air Traveller); mobility scooter (Air Traveller2.0) |
| 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 (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
mobility scooter Page 11 of 46
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510(k) Summary
Document Prepared Date: 2025/12/10
1. Applicant Information
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Address: No. 68 Xinfa Road, Suzhou Industrial Park, Suzhou, Jiangsu, China
Contact: Mr. Chen Lezhang
Tel：+86 139 1626 7666
Email: lezhang@sweetrich.cn; qc@sweetrich.cn
Submission Correspondent:
Primary Contact: Ariel Xiang
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-58817802
Email:shouqiu.xiang@sungoglobal.com
2. Subject Device
Mobility Scooter
Model: Air Classic,Air Traveller,Air Traveller2.0
Classification regulations:21 CFR 890.3800
Product code:INI
Classification:Class II
3. Substantial Equivalence Information
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT),K231472
Classification regulations:21 CFR 890.3800
Product code:INI
Classification:Class II
4. Device Description
The Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries 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.Seat and handlebar can be folded.The maximum load capacity is 120KG.
5. Indication for Use
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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.
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 | Electrical Scooter Air Classic,Air Traveller,Air Traveller2.0 | Electrical Scooter SI SPORT, SI PLUS, MAX SPORT | / |
| 510(k) number | K253075 | K231472 | / |
| 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 | 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 | 4, including two front wheels and two rear wheels | Similar |
| 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 | ＜1m | ≤1m | Same |
| Frame style | Foldable seat, removable battery pack, disassemble for transport | Foldable seat, removable battery pack, disassemble for transport | Same |
| Battery | Llithium-ion battery 24V/12AH | lead-acid 24V/12AH | Different,The lithium battery has passed the IEC 62133-2 test,the subject device also |
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| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| complies with ISO 7176-25,these difference will not cause new safety and effectiveness concerns raised. | |||
| Max loading weight | 120 kg/265 lbs approx | 120 kg/265 lbs approx | Same |
| Max speed | Air Classic:1.73m/s(6.2km/h) Air Traveller&Air Traveller2.0: 1.78m/s(6.4 km/h) | 6.4 km/h | Same |
| Charger | DC 24V/2A | DC 24V/2A | Same |
| Main frame material | Aluminium | Carbon Steel | 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 | Air Classic: 15038mm ,PU Solid tire Air Traveller&Air Traveller2.0: 17848mm, PU Solid tire | 8" (215 x 70 mm) Solid tire | This difference will not cause new safety and effectiveness concerns raised. |
| Rear wheel size/type | Air Classic: 19050 PU Solid tire Air Traveller&Air Traveller2.0: 18848mm PU Solid tire | 8" (215 x 70 mm) Solid tire | |
| Overall Dimension (lengthwidthheight) | Air Classic:1115505881mm Air Traveller&Air Traveller2.0: 1193495858mm | 1210662925mm (Model: S1 SPORT & S1 PLUS) 1260662925mm (Model: MAX SPORT) | Minor difference on scooter dimension will not cause different performance. All safety and performance |
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| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| have been validated with the maximum rated weight dummy. | |||
| Maximum distance of travel on the fully charged battery | Air Classic:16km Air Traveller&Air Traveller2.0: 18.1km | 17 km | Bigger motor capacity keeps longer travel distance. This difference will not cause new safety and effectiveness concerns raised. |
| Turning Radius | Air Classic:1035mm Air Traveller&Air Traveller2.0： 1600mm | 1080-1200 mm | Minor difference on turning radius will not cause new safety and effectiveness concerns raised. |
| Ground clearance | Air Classic:19mm Air Traveller&Air Traveller2.0: 59mm | 40-50 mm | Minor difference on ground clearance will not cause new safety and effectiveness concerns raised. |
| Maximum obstacle climbing | Air Classic:20mm Air Traveller&Air Traveller2.0: 15mm | 20 mm | The difference on maximum obstacle climbing will not cause new safety and effectiveness concerns raised. |
| Slope grade ability | 10 ° | 6 ° | Minor difference on slope grade ability will not cause different performance. No safety or effectiveness concerns raised. |
| Controller | 24V32A,180W-300W | DR50 Dynamic | Both meet the requirements of the ISO 7176-14:2008. |
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| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Not cause new safety and effectiveness concerns raised. | |||
| Motor | Air Classic: Brushless motor,24V/250W Air Traveller&Air Traveller2.0: Brushless motor,24V/180W | 24 V 300W | Minor difference on motor power will not cause safety or effectiveness concerns raised. |
| Base weight (not including battery) | Air Classic:25.47kg Air Traveller&Air Traveller2.0: 22.46kg | 46 kg | Minor difference on scooter weight will not cause different performance. No safety or effectiveness concerns raised. |
Substantial Equivalence Discussion:
The proposed 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 7176-25, and FDA guidance Submission for Mobility Scooter.
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, and the frame materials are the same carbon steel. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. The controller are designed by different company, however the design principles of the controller and Driving system are similar, and both meet the requirements of the ISO 7176-14:2008. 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 ISO 10993-5:2009 & ISO 10993-10:2010.
In conclusion, the technological characteristics, features, specifications, materials, 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
To ensure the safety of the scooter material, the bio-compatibility testing was done to the products. The testing was conducted according to the following standards:
ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
From the test result, we can find the material are safety and can meet the requirements.
7.2 Performance of the products
The following performance data were provided to verify that the subject device met all design 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 7176-14:2008 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 7176-21:2009 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
- ISO16840-10:2021Wheelchairseating — Part 10: Resistance to ignition of postural support devices — Requirements and test method
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- IEC 62133-2:2021 Secondary cells and batteries containing alkaline or other non‑ acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems
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 products have the same technological characteristics, features, specifications, materials, mode of operation, and intended use of the device. To ensure all the key characteristic of the products can meet the requirements, the testing was done and all the results indicate the
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positive conclusion.
Based on the analysis above, we confirm these two products are substantially equivalent.
§ 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).