(58 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.
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The motor and brake system are fixed on the rear wheels.
The max loading of the device is 120KG. Only for one person sit.
This document is a 510(k) clearance letter for an electric wheelchair, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and study designs for AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not available or applicable in this context.
The 510(k) letter focuses on demonstrating substantial equivalence to a predicate device based on:
- Indications for Use: The current device has the same intended use as the predicate (to provide mobility to disabled or elderly individuals).
- Technological Characteristics: Comparison of physical and operational specifications (e.g., motor, battery, dimensions, speed, braking).
- Performance Benchmarking: Validation through adherence to widely accepted international standards for wheelchairs (ISO 7176 series) and biocompatibility (ISO 10993 series), rather than a clinical study comparing human performance with and without AI assistance.
Here's an attempt to structure the available information, acknowledging that many requested fields are not relevant for this type of device clearance:
Device: Electric Wheelchair (QDWP-A01, QDWP-B02)
Study Purpose (Implied from 510(k) clearance): To demonstrate substantial equivalence of the proposed device to legally marketed predicate devices, ensuring it meets established safety and performance standards for powered wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance
For an electric wheelchair, acceptance criteria are typically compliance with relevant ISO standards and specific performance thresholds based on comparative data with predicate devices. The document highlights "Analysis" remarks for minor differences and states that numerous ISO standards were met.
| Acceptance Criteria (Based on ISO Standards and Predicate Device Performance) | Reported Device Performance |
|---|---|
| Braking Distance: ≤ 1.5m (Predicate: 1.5m) | 1.2m (QDWP-A01, QDWP-B02). Analysis: Minor difference on braking distance will not cause different performance. Shorter distance for braking will be more safety. Met ISO 7176-3. |
| Maximum Safe Operational Incline Degree: ≥ 9° (Predicate: 9°) | 10° (QDWP-A01, QDWP-B02). S.E. Met ISO 7176-10. |
| Max Speed Forward: Up to 6 km/h (1.6 m/s) (Predicate: 6 km/h) | 1.8 m/s (6.5 km/h) (QDWP-A01, QDWP-B02). Analysis: Minor difference on Max speed forward of wheels will not cause different performance. Met ISO 7176-6. |
| Max Loading Weight: ≥ 114kg (Predicate: 114kg) | 120kg (QDWP-A01, QDWP-B02). S.E. |
| Maximum Distance of Travel on Fully Charged Battery: ≥ 10.0km (Predicate: 10.0km) | 20.3km (QDWP-A01). 10km (QDWP-B02). S.E. Met ISO 7176-4. |
| Turning Radius: Comparable to predicate (Predicate: 950mm) | 900mm (QDWP-A01, QDWP-B02). Analysis: Minor difference on turning radius will not cause new safety and effectiveness concerns due to the difference. Met ISO 7176-5. |
| Maximum Obstacle Climbing: Comparable to predicate (Predicate: 30mm) | 25mm (QDWP-A01, QDWP-B02). Analysis: Minor difference on obstacle climbing will not cause new safety and effectiveness concerns. Met ISO 7176-10. |
| Biocompatibility: Compliance with ISO 10993 series | Compliance with ISO10993-5, ISO10993-10, ISO10993-23. Materials are safe and meet requirements. (S.E. to predicate) |
| EMC: Compliance with ISO 7176-21 and IEC 60601-1-2 | Compliance with ISO7176-21 and IEC 60601-1-2. (S.E. to predicate) |
| Software Validation: Demonstrated functionality and safety (if applicable) | Software validation carried out. (Met ISO 7176-14 requirements). |
| Mechanical Strength & Durability: Compliance with ISO 7176-8 | Compliance with ISO 7176-8. (Overall performance tests conducted per ISO 7176 series for frame material differences). |
| Flammability of Seating/Backrest Materials: Compliance with ISO 16840-10 | Compliance with ISO 16840-10. Assured to be under the same safety level. |
| Power & Control Systems: Compliance with ISO 7176-14 | Compliance with ISO 7176-14. No new safety and effectiveness concerns due to differences in motor/controller. |
| Static & Dynamic Stability: Compliance with ISO 7176-1 and ISO 7176-2 | Compliance with ISO 7176-1 and ISO 7176-2. |
| Batteries & Chargers: Compliance with ISO 7176-25 | Compliance with ISO 7176-25. |
| Risk Analysis: Developed in accordance with ISO 14971 | Risk Analysis developed in accordance with ISO 14971: 2019. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in terms of a "sample size" of individual devices, as this is typically based on testing a representative number of units to demonstrate compliance with standards. Testing would involve a few prototypes/production units.
- Data Provenance: The device manufacturer is Jinhua Qidian Vehicle Co. Ltd. in China. The testing would have been conducted by the manufacturer or accredited testing laboratories, likely in China, to the specified ISO standards. The data is prospective in the sense that it's generated for the clearance submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. For a physical medical device like an electric wheelchair, "ground truth" is established by direct physical measurements, engineering tests, and adherence to objective performance standards (e.g., braking distance, speed, stability under load). It does not involve expert interpretation of medical images or clinical outcomes that require medical experts to establish a "ground truth."
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in image interpretation or clinical diagnosis. This device's performance is objectively measured against engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop clinical study comparing human performance with and without AI assistance would be conducted for this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no "algorithm only" performance for an electric wheelchair in the sense of an AI/ML model. The device operates mechanically and electronically, with its "performance" being its ability to move, brake, and maintain stability.
7. The Type of Ground Truth Used
- Engineering Standards and Objective Measurements: The "ground truth" for this device's performance is established by recognized international engineering, safety, and quality standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility). Performance is measured directly against these benchmarks and compared to a predicate device. This includes physical measurements (dimensions, speed), mechanical tests (strength, stability, braking), electrical tests (battery, motor, EMC), and material tests (biocompatibility, flammability).
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML system that requires training data. The "training" for the device would be its design and manufacturing processes.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI/ML training set for this device. The design specifications and performance objectives are based on engineering principles and regulatory requirements for powered wheelchairs.
FDA 510(k) Clearance Letter - Electric Wheelchair
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Jinhua Qidian Vehicle Co. Ltd
℅ Ariel Xiang
Consultant
Shanghai Sungo Management Consulting Co. Ltd.
14th Floor, 1500# Century Avenue
Shanghai, Shanghai 200122
China
Re: K251248
Trade/Device Name: Electric Wheelchair (qdwp-a01,qdwp-b02)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: April 23, 2025
Received: April 23, 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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K251248 - 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).
Page 3
K251248 - Ariel Xiang Page 3
Sincerely,
Julia E. Slocomb 2025.06.20
-S 11:44:26 -04'00'
for, 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
Page 4
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.
Submission Number (if known)
K251248
Device Name
ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
Indications for Use (Describe)
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.
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."
Page 5
JINHUA QIDIAN VEHICLE CO.LTD
#8.NO308. WeiyeRoad, Jiangtang, Wucheng,Jinhua, Zhejiang, China
510(K) Summary
Document Prepared Date: 2025/4/21
A. Applicant
Name: JINHUA QIDIAN VEHICLE CO.LTD
Address: #8.NO308. WeiyeRoad, Jiangtang, Wucheng,Jinhua, Zhejiang, China
Contact Person: Qunbao Yang
Email: 568438678@qq.com
Submission Correspondent:
Primary contact: Ms.Ariel Xiang
Title: Senior Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: shouqiu.xiang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
Title: Technical Director
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: zxfda@sungoglobal.com
B. Device
Trade Name: Electric wheelchair
Common Name: Powered wheelchair
Model(s): QDWP-A01,QDWP-B02
Regulatory Information
Classification Name: Powered wheelchair
Classification: Class II.
Product code: ITI
Regulation Number: 890.3860
Review Panel: Physical Medicine
C. Predicate device
510K number: K113463
power wheelchair, PL00l
SUZHOU KD Medical Appliance Co. Ltd.
Page 6
Reference Device
K211647
Electrically Powered Wheelchair,HP358EA
Kunshan Hi-Fortune Health Products Co., Ltd
D. Indications for use of the device
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.
E. Device Description:
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The motor and brake system are fixed on the rear wheels.
The max loading of the device is 120KG. Only for one person sit.
F. Comparison with predicate Device
Table 1 General Comparison
| Elements of Comparison | Subject Device (K251248) | Predicate Device (K113463) | Reference Device (K211647) | Remark |
|---|---|---|---|---|
| Manufacturer | JINHUA QIDIAN VEHICLE CO.LTD | SUZHOU KD Medical Appliance Co. Ltd. | Kunshan Hi-Fortune Health Products Co., Ltd | -- |
| Common or | Electric wheelchair | Power Wheelchair | Electrically Powered | -- |
Page 7
| Usual name | ir | Wheelchair |
|---|---|---|
| Model(s) | QDWP-A01 QDWP-B02 | PL00l |
| Classification | Class II | Class II |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 |
| Product code | ITI | ITI |
| Indications 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. |
| Intended user | disabled or elderly person limited to a seated position. | disabled or elderly person limited to a seated position. |
Page 8
| Use condition | indoor and outdoor use | 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 | 6, including two front wheels and two rear wheels, two anti-tip wheels | S.E |
| Function of wheels | Front wheels:driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction | Front wheels:driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable | S.E |
| Movement control | By Joystick control | By Joystick control | By Joystick control | S.E |
Page 9
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Direct drive on the rear wheels | S.E |
|---|---|---|---|---|
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | S.E |
| Braking distance | 1.2m | 1.5 m | 0.8m | Analysis: Minor difference on braking distance will not cause different performance. Shorter distance for braking will be more safety. |
| Maximum safe operational incline degree | 10 ° | 9 ° | 10° | S.E |
| Armrest | PP | PU | PU | Analysis: Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series. |
Page 10
| Main frame material | Aluminum alloy | Steel | Aluminum alloy | Aluminum alloy QDWP-A01 is Same as Predicate Device; QDWP-B02 is different. Analysis: 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 |
Page 11
| series. | ||||
|---|---|---|---|---|
| Back cushion | Nylon | PU foam covered by nylon fabric cloth | Terylene | S.E Same as Predicate Device. |
| Seat cushion | Nylon | PU foam covered by nylon fabric cloth | Terylene | |
| Overall length | 1120mm | 970mm | 880mm | 990mm Analysis: Minor difference on wheelchair dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Overall width | 600mm | 660mm | 570mm | 620mm |
| Folded Dimension (lengthwidthheight) | 710600450mm | 680460770mm | 750570400mm | 620mmX550mmX850mm |
Page 12
| Front wheel size/type | 200mm×50mm PU Solid tire (8 inch) | 200mm×45mm (8 inch) PU Solid tire | 6" x 2"/PU Solid tire | 8" PU tire | S.E Same as Reference Device. |
|---|---|---|---|---|---|
| Rear wheel size/type | 10inch×2.0inch Rubber Filler | 305mm×43mm (12 inch) PU Solid tire | 8″x 2.4″/ PU Solid tire | 12" Pneumatic tires | DWPB02 is same as reference device. Analysis: Minor difference on dimension of wheels will not cause different performance. |
| Max speed forward | 1.8 m/s (6.5km/h) | Up to 6 km/h (1.6 m/s), adjustable | 1.4 m/s | Analysis: Minor difference on Max speed forward of |
Page 13
| wheels will not cause different performance. | ||||
|---|---|---|---|---|
| Max loading weight | 120kg | 114kg (251lbs) | 120kg | S.E |
| Maximum distance of travel on the fully charged battery | 20.3km | 10.0km | 20 km | 10km S.E |
| Battery | Lithium-ion Battery 24V, 10Ah,2PCS | Lead Acid Battery, 12V, 12Ah,2PCS | li-ion battery pack; rechargeable, 24 VDC 20Ah | li-ion battery; rechargeable, 25.2VDC, 10.4Ah Analysis: QDWP-A01 is same , QDWP-B02 is different. The performance of batteries and charger of device meet the Requirements of ISO |
| Battery charger | Off-board charger, Input: 100-240V~1.8A, 50/60Hz Output: 24V, 3.0A | Off-board charger, Input:100/240V,50/60Hz/55W Output:24V-29.6V,1.8A | Off-board charger Input: 110-240V, 50- 60Hz, Output: 24 Vdc, 2A; | Off-board charger, Input :100-240VAC, 50-60Hz, 1.2-0.5A DC output: 24Vdc2A |
Page 14
| 7176-25. | ||||
|---|---|---|---|---|
| Motor | Brushless Motor, 24VDC, 250W | Brushed motor, 24VDC, 250W | Brushless DC motor; 24VDC; 180W; 2pcs | DC Brushed Motor, 24Vdc 250W;2pcs QDWP-B02 is same as reference device. The type of QDWP-A01 is predicate device. Analysis: Minor difference on motor power. Both meet the require of ISO 7176-14 standard. It will not cause new safety and effectiveness concerns. |
| Electronic controller | 24V 40A | 24V35A | Brushless dual-drive rocker controller | 24V 35A QDWP-B02 is same as reference device. Analysis: |
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| Both of the control systems are evaluated according to standard ISO 7176-14:2008 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. | ||||
|---|---|---|---|---|
| Turning Radius | 900mm | 950mm | 800 mm | 500mm Analysis: Minor difference on turning radius will not cause new safety and effectiveness concerns due to the difference. |
Page 16
| Maximum obstacle climbing | 25mm | 30 mm | 30mm | Analysis: Minor difference on obstacle climbing will not cause new safety and effectiveness concerns. |
|---|
Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 ,ISO10993-10 ,ISO10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 and IEC 60601-1-2 | ISO7176-21 and IEC 60601-1-2 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
G. 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, ISO7176-22,ISO 7176-25, IEC 60601-1-2 and FDA guidance Submission for Power Wheelchair.
The indications for use, design, structure, composition, principle of operation and energy source of proposed device and predicate device are identical.The dimensions and performance parameters are similar.The main differences are motor and controller.
The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3. Turning radius, Maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2 and ISO 7176-10.
The materials in contact with human tissue are identical for both proposed device and predicate device.The biocompatibility of the proposed device and predicate device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
Page 17
The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. Therefore, both devices are assured to be under the same safety level.
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.
H. Product Performance
a) Product Material Safety
To ensure the safety of the wheelchair 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 skin sensitization
- ISO 10993-23 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.
b) 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.
- 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 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
Page 18
- 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 proceduresd
- ISO 7176-25：2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020 8.11.
I. Conclusion
The proposed device and predicate device 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 positive conclusion.
Based on the analysis above, we confirm these two products are substantially equivalent.
§ 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).