(68 days)
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.
The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.
The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Electric Wheelchair has 7 inch front wheel and 12 inch rear tire.
Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.
The braking time is about 2s, and the braking distance is ≤1.5m.
The provided FDA 510(k) clearance letter and summary are for an Electric Wheelchair (HG-630). This document specifies performance criteria based on engineering and safety standards (ISO 7176 series), not on AI/algorithm performance. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable to this device.
The study proves the device meets acceptance criteria through a comparison to a predicate device and adherence to established international standards for wheelchairs.
Here's a breakdown of the acceptance criteria and proof of performance based on the provided text:
Acceptance Criteria and Device Performance for the Electric Wheelchair (HG-630)
The acceptance criteria for the Electric Wheelchair (HG-630) are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K240913) and compliance with relevant international performance and safety standards, specifically the ISO 7176 series and ISO 10993 series. The "performance" of the device is assessed against a set of engineering and safety specifications that ensure it functions safely and effectively as a powered wheelchair.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the adherence to a comprehensive set of ISO standards for wheelchairs and by demonstrating that the device's technical specifications are comparable to or meet the safety requirements outlined by the predicate device and those standards.
| Acceptance Criterion (Based on ISO Standards & Predicate Comparison) | Reported Device Performance (HG-630) | Remark/Proving Met Criteria |
|---|---|---|
| Material Biocompatibility (ISO 10993-5, -10, -23) | All user directly contacting materials compliant. | Demonstrated compliance with ISO10993-5, ISO10993-10, and ISO 10993-23 requirements. |
| Electromagnetic Compatibility (EMC) (ISO 7176-21 & IEC 60601-1-2) | EMC performance results meet requirements. | Demonstrated compliance with ISO 7176-21 & IEC 60601-1-2. |
| Labeling (FDA Regulatory) | Conforms to FDA Regulatory requirements. | Declared conformity to FDA Regulatory. |
| Static Stability (ISO 7176-1) | Test results meet design specification. | Determined after testing according to ISO 7176-1. |
| Dynamic Stability (ISO 7176-2) | Test results meet design specification. | Determined after testing according to ISO 7176-2. |
| Brake Effectiveness (ISO 7176-3) | Brake effectiveness meets design specification. Braking time: ~2s, Braking distance: ≤1.5m | Determined after testing according to ISO 7176-3. Note: Predicate brake distance was ≤1.5m; the subject device's braking distance is stated as ≤0.8m in Table 1, then back to ≤1.5m in description. The ≤0.8m is an improvement. |
| Theoretical Distance Range (ISO 7176-4) | 13.3 km (Max. distance of travel on fully charged battery) | Determined after testing according to ISO 7176-4. Predicate 20km, but difference does not affect safety/effectiveness. |
| Dimensions & Mass (ISO 7176-5, -6) | Overall: 1070×560×870 mm; Folded: 710×370×750 mm | Determined after testing according to ISO 7176-5 and -6. Minor differences from predicate are acceptable. |
| Seating & Wheel Dimensions (ISO 7176-7) | 7" front, 12" rear wheel; seating dimensions determined. | Determined after testing according to ISO 7176-7. |
| Static, Impact & Fatigue Strengths (ISO 7176-8) | All test results meet requirements in Clause 4. | Demonstrated compliance with ISO 7176-8. |
| Climatic Tests (ISO 7176-9) | Device continues to function according to manufacturer's specifications. | Demonstrated compliance with ISO 7176-9. |
| Obstacle-Climbing Ability (ISO 7176-10) | 25mm (Maximum obstacle climbing) | Determined after testing according to ISO 7176-10. Predicate 20mm, subject device shows improvement. |
| Test Dummies (ISO 7176-11) | Test dummies meet requirements. | Confirmed for testing in ISO 7176 series. |
| Coefficient of Friction of Test Surfaces (ISO 7176-13) | Determined for use in other 7176 series tests. | Confirmed for use in other 7176 series tests. |
| Power & Control Systems (ISO 7176-14) | All test results meet requirements. | Demonstrated compliance with ISO 7176-14. |
| Documentation & Labeling (ISO 7176-15) | Information disclosure, documentation, and labeling meet requirements. | Demonstrated compliance with ISO 7176-15. |
| Resistance to Ignition (ISO 7176-16 / ISO 16840-10) | Performance meets requirements. | Demonstrated compliance with ISO 16840-10. |
| Maximum Forward Speed | 5.76 km/h (1.6 m/s) | Slightly different from predicate (6-8 km/h), but test results confirm safety and performance per ISO 7176-6. |
| Maximum Backward Speed | Less than 3.6 km/h (1.0 m/s) | Slightly different from predicate (Less than 3 km/h), but acceptable. |
| Maximum Loading Weight | 100 kg | Same as predicate. |
| Maximum Safe Operational Incline Degree | 10 ° | Improved over predicate (6 °), stated as more convenient. |
| Turning Radius | 925mm | Within range of predicate (HBLD3-B: 875mm, HBLD3-E: 1050mm), complies with ISO 7176-5. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a dataset for AI/algorithm validation, as this is an electro-mechanical device. The performance is based on physical testing of the device itself.
- Data Provenance: The tests are conducted according to international standards (ISO series) which specify the methodologies. The manufacturer is Zhejiang Automwheel Tech Co., Ltd. from China. The testing would have been conducted in a laboratory environment, likely by the manufacturer or a third-party testing facility, to certify compliance with the stated ISO standards. This is akin to prospective testing on a manufactured unit.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For an electric wheelchair, "ground truth" is established by adherence to engineering performance metrics and safety standards defined by organizations like ISO. There are no human "experts" establishing subjective "ground truth" in the way one would for diagnostic AI. The performance metrics are objective and measurable (e.g., braking distance, stability angles, dimensions).
4. Adjudication Method for the Test Set
- Not Applicable. As objective engineering parameters and safety standards are being met, there is no need for adjudication in the context of multiple human interpretations as there would be in, for example, medical image analysis. The tests either pass or fail the defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Not Applicable. This is not an AI/algorithm-assisted diagnostic device. Therefore, a comparative effectiveness study involving human readers' improvement with or without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an electro-mechanical product. It does not have a "standalone algorithm" in the typical sense of AI/ML. Its performance is inherent to its design and functionality, which is then tested against industry standards.
7. The Type of Ground Truth Used
- Engineering and Safety Standard Compliance: The "ground truth" for this device's performance relies on objective, measurable physical parameters and functionalities as defined by established international standards (ISO 7176 series for performance, ISO 10993 series for biocompatibility, etc.). These standards set the benchmarks for what constitutes safe and effective operation for a powered wheelchair.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires machine learning training data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set for AI/ML was used. The "ground truth" (i.e., compliance with performance and safety standards) is established through established test procedures defined by the ISO standards themselves.
FDA 510(k) Clearance Letter - Electric Wheelchair (HG-630)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
Zhejiang Automwheel Tech Co., Ltd.
℅ Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China
Re: K251285
Trade/Device Name: Electric Wheelchair (HG-630)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: June 13, 2025
Received: June 13, 2025
Dear Kiwi Xu:
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.
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K251285 - Kiwi Xu
Page 2
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).
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-
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K251285 - Kiwi Xu
Page 3
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).
Sincerely,
Julia E. Slocomb -S
2025.07.02 16:40:42 -04'00'
for Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and Physical Medicine Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
| Field | Value |
|---|---|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251285 |
| Please provide the device trade name(s). | Electric Wheelchair (HG-630) |
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)
Electric Wheelchair
Page 10 of 51
Page 5
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
510k summary
K251285
Submitter:
Name: Zhejiang Automwheel Tech Co., Ltd.
Address: 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China
Contact: Zhihao Liu
Email: info@automwheel.com
Device:
Device Name: Electric Wheelchair
Model: HG-630
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
Predicate device:
510K number: K240913
Device Name: Electric Wheelchair
Model: HBLD3-B, HBLD3-E
Manufacturer: Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd
Device description:
The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.
The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel
1 of 6
Page 6
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
(including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Electric Wheelchair has 7 inch front wheel and 12 inch rear tire.
Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.
The braking time is about 2s, and the braking distance is ≤1.5m.
Indication for use:
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.
Product Parameter
Table 1 General Comparison
| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Automwheel Tech Co., Ltd. | Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd | - |
| Common or Usual name | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | HG-630 | HBLD3-B, HBLD3-E | -- |
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Page 7
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
|---|---|---|---|
| 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. | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear Wheels | 4, including two front wheels and two rear Wheels | Same |
| 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 | Same |
| 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 electronic brake system | Automatic electromagnetic brake system | Same |
| Braking distance | ≤0.8 m | ≤1.5 m | Analysis: Larger braking distance and safe operational incline degree of subject bring more convenient for the use environment. |
| Maximum safe operational incline degree | 10 ° | 6 ° | |
| Armrest | PU (polyurethane) | ABS | Analysis: Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility tests have been conducted to verify the safety and effectiveness of the material. |
| Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 V-29.6V, 1.8A; | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Same |
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Page 8
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
|---|---|---|---|
| Main frame material | Aluminum alloy | Aluminum Alloy | Same |
| Seat cushion | Polyester fiber | Polyester fabric | Same |
| Back cushion | Polyester fiber | Polyester fabric | Same |
| Overall Dimension (lengthwidthheight) | 1070×560×870 mm | HBLD3-B model: 960×580×890 mm HBLD3-E model: 1090×640×900 mm | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded Dimension (lengthwidthheight) | 710×370×750 mm | HBLD3-B model: 890×600×380 mm HBLD3-E model: 730×350×950 mm | |
| Front wheel size/type | 8"/ Solid tyre | 7" x 1.75"/PU Solid tire | Analysis: Different sizes and type of rear wheel will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. |
| Rear wheel size/type | 12" x 1.75"/ Solid tyre | 12" x 2.125" pneumatic tire | |
| Max speed forward | 5.76 km/h(1.6 m/s) | 6-8 km/h (1.6-2.2 m/s), adjustable | Analysis: Slightly difference on the parameter will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176-6:2018. |
| Max Speed backward | Less than 3.6 km/h (1.0 m/s) | Less than 3 km/h (0.8m/s) |
4 of 6
Page 9
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
|---|---|---|---|
| Max loading weight | 100 kg | 100 kg | Same |
| Battery | 12V 12Ah Lead-acid battery×2 | Li-ion battery pack; rechargeable, 24 V DC 5.2 Ah*2 | Analysis: The subject device complies with ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs and EMC testing, these differences do not affect safety and effectiveness. |
| Maximum distance of travel on the fully charged battery | 13.3km | 20km | Analysis: The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness. |
| Motor | DC motor; 24VDC; 250W; 160 r/min | Brushless DC motor; 24VDC; 150W; 2pcs | |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Same |
| Turning Radius | 925mm | HBLD3-B model: 875 mm HBLD3-E model: 1050 mm | Analysis: The predicate device and subject device have different dimensions. Both comply with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space so these differences do not affect safety and effectiveness. |
| Maximum obstacle climbing | 25mm | 20mm |
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Page 10
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
Table 2 Safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | Same |
| EMC | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | Same |
| ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | Same |
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | Same |
| ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | Same |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | Same |
| ISO7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | Same |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | Same |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | Same |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | Same |
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Page 11
Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | Same |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | Same |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | Same |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | Same |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | Same |
| ISO7176-16/ ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | Same |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | Same |
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 and FDA guidance Submission for Power Wheelchair.
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 (tipping angle), The Dynamic stability (Safe Gradient Maximum Gradient), 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.
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Zhejiang Automwheel Tech Co., Ltd.
1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town,
Wucheng District, Jinhua City, Zhejiang Province, China
The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO10993-10:2010/ ISO 10993-23:2021.
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.
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.
Substantially Equivalency Conclusion:
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices, K240913 Power Wheelchair from Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd.
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§ 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).