(48 days)
The electric wheelchair 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 Electric wheelchair, Model P2, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control board that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The electric wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
N/A
FDA 510(k) Clearance Letter - Electric Wheelchair (Model P2)
Page 1
September 18, 2025
Superpi Robot Co., Ltd.
℅ Ivy Wang
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai, SH 200122
China
Re: K252428
Trade/Device Name: Electric Wheelchair (Model P2)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: August 1, 2025
Received: August 1, 2025
Dear Ivy Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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" (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).
Page 2
K252428 - Ivy Wang Page 2
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
K252428 - Ivy Wang 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
Page 4
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. K252428
Please provide the device trade name(s). Electric Wheelchair (Model P2)
Please provide your Indications for Use below.
The electric wheelchair 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)
Electric Wheelchair Page 11 of 39
Page 5
510(k) Summary
I. SUBMITTER
Name: Superpi Robot Co., Ltd.
Address: Room N901, 9th Floor, Yungu Fudi Center, No.181 Jingda Road, Hangzhou City, Zhejiang Province, China
Name of contact person: LI XUAN
Telephone: +86 18862637660
Fax: +86-571-87969998
Email: lixuan@superpirobot.com
Date prepared: 2025-09-18
II. Device
Device trade name: Electric Wheelchair
Model: Model P2
Common name: Power Wheelchair
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
III. Predicate device
K220747
Power Wheelchair, N5515B
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
IV. Device description
The Electric wheelchair, Model P2, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake
Page 6
system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control board that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The electric wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
V. Indication for use
The electric wheelchair 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.
VI. Comparison of technological characteristics with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Manufacturer | Superpi Robot Co., Ltd. | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | / |
| Proprietary name, model | Electric Wheelchair, Model P2 | Power Wheelchair, N5515B | / |
| 510(k) number | K252428 | K220747 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
Similarities
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Indication for use | The electric wheelchair 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 Power Wheelchair 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 |
| Intended user | disabled people with mobility difficulties and elderly people | disabled people with mobility difficulties and | Same |
Page 7
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| elderly people | |||
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
Table 2 Basic Parameters Comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Device length | 37.80" (960mm) | 37" (940mm) | Minor difference on wheelchair dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Device width | 24.41" (620mm) | 24.01" (610mm) | |
| Stowage length | 37.80" (960mm) | 28.35" (720mm) | |
| Stowage width | 24.41" (620mm) | 12.20" (310mm) | |
| Stowage height | 16.93" (430mm) | 24.01" (610mm) | |
| Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and directionAnti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable. | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and directionAnti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable. | Same |
| Front wheel size/type | 7.87" / PU Solid tire | 7"/ PU Solid tire | Minor difference on dimension of driven wheel will not cause different performance. |
| Rear wheel size/type | 8.86"/ PU Solid tire | 8.5″/ PU Solid tire | |
| Total mass | 57.3lbs (26kg) | 35.3lbs (16kg) | Minor difference on total mass will not raise any new safety and effectiveness concerns. |
| Main frame material | Carbon fiber material | Carbon fiber material | Same |
| Folding method | front and rear close | front and rear close | Same |
Page 8
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Movement control method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | Same |
| Battery charger | Off-board chargerInput: 100-240V, 50/60Hz, 2.5A,Output: 29.4 Vdc, 2.8A; | Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A; | Minor difference on battery charger do not affect effectiveness and safety performance. |
| back cushion | Poly(ethylene terephthalate) (PET) | Polyester fabric | Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of subject devices as biocompatibility complied with ISO 10993 series. |
| seat cushion | Poly(ethylene terephthalate) (PET) | rubber patch cloth and Oxford fabric | |
| Armrest | ABS | Polyurethane (PU) | |
| Max loading weight | 300lbs (136kg) | 300lbs (136kg) | Same |
| Maximum obstacle climbing | 1.18" (30 mm) | 1.57" (40 mm) | Minor difference in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| Max speed forward | Up to 6 km/h, adjustable | Up to 6 km/h, adjustable | Same |
| Maximum safe operational incline degree | 10° | 9 ° | minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated according to standard ISO 7176 series. |
| Braking distance | 35.4" (0.9 m) | ≤59" (1.5 m) | minor difference on braking distance will not cause different performance. Shorter distance for braking will be more safety. |
Page 9
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Battery | li-ion battery pack; rechargeable, 24 VDC 10Ah | li-ion battery pack; rechargeable, 24 VDC 12Ah | minor difference on battery capacity will not cause different performance. This difference will not raise any new safety and effectiveness concerns. |
| Maximum distance of travel on the fully charged battery | 10.07mi (16.2km) | 9.32mi (15 km) | Minor difference on travel distance will not cause different performance. This difference will not raise any new safety and effectiveness concerns |
| Motor | Brushless DC motor; 24VDC; 250W; 2pcs | Brushless DC motor; 24VDC; 250W; 2pcs | Same |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Same |
| Turning Radius | 32.48" (825mm) | 35.43" (900 mm) | The minor difference in the turning radius is caused by different size of wheelchair and may cause a little bit inconvenience when it turns in a narrow space while the minor difference will not raise any new safety and effectiveness concerns. |
Table 3 Safety Comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO 10993-1 | All user directly contacting materials are compliance with ISO 10993-1 | Same |
| EMC | ISO 7176-21 & IEC60601-1-2 | ISO 7176-21 & IEC60601-1-2 | Same |
| Performance | ISO 7176 seriesIEC 62133-2 | ISO 7176 series | Same |
| Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
VII. Summary of substantial equivalence discussion
The proposed device and predicate device are complying to the same ISO standards, 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
Page 10
7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2020, IEC 62133-2:2017 and FDA guidance document for wheelchairs.
The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ control criteria following above mentioned standards. And the test results show that the subject product is substantially equivalent to the predicate device in performance.
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability, The Dynamic stability, Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to ignition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers.
The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993 requirements.
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.
VIII. Summary of non-clinical testing
Performance testing-bench
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2019.
- Software validation
- 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
Page 11
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 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 – Part 25: Batteries and chargers for powered wheelchairs
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
Biocompatibility of patient-contacting material
The biocompatibility of the subject device was determined due to the low-biocompatibility-risk
Page 12
materials policy in Attachment G of FDA's 2023 Guidance on "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" was invoked for eligible tissue-contacting materials.
IX. 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 electric wheelchair to its predicate device.
X. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K220747.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).