(220 days)
The "eFOLDi Navigator Powerchair STPC-A" 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 eFOLDi Navigator Powerchair STPC-A 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 wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable.
The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm.
The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black.
The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant.
The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires.
The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop.
The wheelchair is equipped with anti-tipper device.
This FDA 510(k) clearance letter is for a physical medical device (eFOLDi Navigator Powerchair), not an AI/software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI performance is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO and IEC standards for wheelchairs.
However, I can extract the acceptance criteria and study information related to the device's physical performance as detailed in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Reference Standard Results) |
|---|---|
| Biocompatibility: All user directly contacting materials compliant with ISO10993-1 requirements | Compliance with ISO10993-1 requirements |
| Static Stability: ISO 7176-1 | Compliant with ISO 7176-1 |
| Dynamic Stability: ISO 7176-2 | Compliant with ISO 7176-2 |
| Brake Effectiveness: ISO 7176-3 | Compliant with ISO 7176-3 |
| Energy Consumption/Range: ISO 7176-4 | Compliant with ISO 7176-4 |
| Overall Dimensions, Mass, Maneuvring Space: ISO 7176-5 | Compliant with ISO 7176-5 |
| Max Speed, Acceleration, Deceleration: ISO 7176-6 | Compliant with ISO 7176-6 |
| Seating & Wheel Dimensions: ISO 7176-7 | Compliant with ISO 7176-7 |
| Static, Impact & Fatigue Strengths: ISO 7176-8 | Compliant with ISO 7176-8 |
| Climatic Tests: ISO 7176-9 | Compliant with ISO 7176-9 |
| Obstacle-Climbing Ability: ISO 7176-10 | Compliant with ISO 7176-10 |
| Test Dummies: ISO 7176-11 | Compliant with ISO 7176-11 |
| Power and Control Systems: ISO 7176-14 | Compliant with ISO 7176-14 |
| Resistance to Ignition of Postural Support Device: ISO 16840-10: 2021 | Compliant with ISO 16840-10: 2021 |
| Safe Operation of Portable Sealed Secondary Lithium Cells and Batteries: IEC 62133-2 | Compliant with IEC 62133-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size (number of units) used for each non-clinical performance test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests performed by the manufacturer (SunTech UK Ltd.) likely in a controlled laboratory or testing facility setting, rather than human data. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of data acquisition, as it's not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a physical device like a powerchair, "ground truth" as it relates to expert consensus for diagnostic accuracy or similar AI contexts is not relevant. Performance is determined by objective physical tests against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies (e.g., medical image interpretation). For physical device testing, the outcome is determined by whether the device passes or fails the specified standard criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/SaMD device, so MRMC studies involving human readers or AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is not an AI/SaMD device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by compliance with internationally recognized engineering and safety standards for wheelchairs and their components (ISO 7176 series, ISO 10993-1, ISO 16840-10, IEC 62133-2). These standards define objective, measurable criteria that the device must meet.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/SaMD device. There is no "training set" in the context of a physical powerchair's mechanical and electrical performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/SaMD device and has no training set.
FDA 510(k) Clearance Letter - eFOLDi Navigator Powerchair
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 8, 2025
SunTech UK Ltd.
Jinfeng Ning
Official Correspondent
25 Ormside Way, Holmethorpe Industrial Estate
Rehill, Surrey RH1 2LW
United Kingdom
Re: K243110
Trade/Device Name: eFOLDi Navigator Powerchair (STPC-A)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: May 2, 2025
Received: May 2, 2025
Dear Jinfeng Ning:
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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K243110 - Jinfeng Ning 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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Sincerely,
Heather L. Dean -S
Heather Dean, PhD
Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243110
Device Name
eFOLDi Navigator Powerchair (STPC-A)
Indications for Use (Describe)
The "eFOLDi Navigator Powerchair STPC-A" 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.
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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:
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Page 5
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
1.0 Submitter Information
SunTech UK Ltd.
25 Ormside Way, Holmethorpe Industrial Estate,
Redhill, Surrey, RH1 2LW, UK
Tel： (44)-0-203 143 5168
Submitter's FDA Registration Number：N/A
Submission Correspondent
Jinfeng Ning
Manton Business and Technology Services
37 Winding Ridge, Oakland, NJ 07436
Tel: 608-217-9358
Email: jfning@gmail.com
Date of Summary: September 27, 2024
2.0 Device Information
Proprietary Name: eFOLDi Navigator Powerchair STPC-A
Common Name: Electric Wheelchair
Classification Name: Powered Wheelchair
Device Classification: II
Regulation Number: 21 CFR 890.3860
Product Code: ITI
Panel: Physical Medicine
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3.0 Predicate Device Information:
Manufacturer: Ningbo Baichen Medical Devices Co., Ltd.
Product Name: Power Wheelchair (Model: BC-EA8000)
510(K) #: K232121
4.0 Device description:
The eFOLDi Navigator Powerchair STPC-A 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 wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable.
The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm.
The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black.
The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant.
The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires.
The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop.
The wheelchair is equipped with anti-tipper device.
5.0 Indications for Use:
The eFOLDi Navigator Powerchair STPC-A 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.
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6.0 Comparison to Predicate Devices
The "eFOLDi Scooter, Lite" manufactured by "SUNTECH UK LTD" is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.
(1) K232121, "Power Wheelchair (Model:BC-EA8000)", manufactured by "Ningbo Baichen Medical Devices Co., Ltd."
The following table shows similarities and differences of use, design, and material between our devices and the predicate device.
Table 6.1: Comparison of Intended Use, Design, and Material
| Characteristic | Subject Device | Predicate Device (K232121) | Substantial Equivalence |
|---|---|---|---|
| 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. | S.E. |
| Operating surface & environment | Indoor and outdoor use | Indoor and outdoor use | S.E. |
| Number of wheels | 4, including two front wheels and two rear wheels | 4, including two front wheels and two rear wheels | S.E |
| Movement control method | By Joystick control and attendant control | By Joystick control | Similar |
| Drive Style (e.g., rear, mid, front) | Rear-wheel drive | Rear-wheel drive | S.E. |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | S.E. |
| Braking distance | ≤ 1.5 m | ≤ 1.5 m | S.E. |
| Maximum safe operational incline degree | 6° | 6° | S.E. |
| Armrest | PVC leather foam | PU | Different |
| Battery charger | Off-board charger, input: 100-240V~1.8A,50/60Hz. Output: 29.4Vdc,2.0 A | Off-board charger input: 100-240V, 50/60Hz, 1.5A. Output: 24Vdc, 2A | Similar |
| Main frame material | Magnesium alloy | Aluminum Alloy | Similar |
| Back cushion | Polyester fabric | Polyester fabric | S.E. |
| Seat cushion | Polyester fabric | Rubber patch cloth and Oxford fabric | S.E. |
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| Overall Dimensions (lengthwidthheight) | 1080 x 590 x 890 mm | 950 x 625 x 930 mm | Similar |
|---|---|---|---|
| Folded Dimensions (lengthwidthheight) | 340 x 590 x 890 mm | 775 x 440 x 410 mm | Similar |
| Front wheel size / type | 8″ / PU Solid tire | 5.9″x1.90″ / PU Solid tire | Similar |
| Rear wheel size / type | 11.5″ / PU Solid tire | 10.6″x1.97″ / PU Solid tire | Similar |
| Max speed Forward | 5.6 km/h | Up to 6 km/h | S.E. |
| Max speed backword | Less than 3Km/h(0.78m/s) | Less than 3km/h(0.5m/s) | Similar |
| Max loading weight | 120Kg (≈264.5lbs) | 100Kg (≈220lbs) | Similar |
| Batteries | Rechargeable Li-ion battery:24VDC, 10Ah, 240Wh | Lithium 24V 6Ah | Different |
| Motor | Brushless DC motor; 24VDC; 180W, 2pcs | Brushless DC motor; 24VDC; 150W, 2pcs | Similar |
| Turning Radius | 600mm | 900mm | Similar |
| Maximum obstacle climbing | 50mm | 40mm | Similar |
The minor differences between the subject device and predicate device do not raise any concerns in terms of safety and effectiveness.
7.0 Non-Clinical Study Summary
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Tests | Standard |
|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-1 requirements |
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| Performance | ISO 7176-1: Wheelchairs – Part 1: Determination of static stability |
|---|---|
| ISO 7176-2: Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs | |
| ISO 7176-3: Wheelchairs - Part 3: Determination of effectiveness of brakes | |
| ISO 7176-4: Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | |
| ISO 7176-5: Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | |
| ISO 7176-6: Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | |
| ISO 7176-7: Wheelchairs - Part 7: Measurement of seating and wheel dimensions | |
| ISO 7176-8: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths | |
| ISO 7176-9: Wheelchairs - Part 9: Climatic tests for electric wheelchairs | |
| ISO 7176-10: Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | |
| ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies | |
| ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | |
| ISO 16840-10: 2021 Wheelchair seating –Part 10: Resistance to ignition of postural support device – Requirements and test methods | |
| IEC 62133-2: Specifies requirements and tests for the safe operation of portable sealed secondary lithium cells and batteries containing non-acid electrolyte, under intended use and reasonably foreseeable misuse. |
8.0 Clinical Study Summary
Clinical study is not performed for this product.
9.0 Conclusion
The conclusions drawn from the nonclinical tests that demonstrate is that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).