(90 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 entire wheelchair can be disassembled, making it easy to carry. The wheelchair comes equipped with an electronically controlled rising seat that allows the user 280mm/11" of seat height adjustment using the joystick. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lead-acid Battery as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon steel. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.
The provided text is a 510(k) summary for an electrically powered wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.
Therefore, many of the requested elements of information, such as sample sizes, data provenance, expert qualifications, and MRMC study details, are not applicable or not available in this type of document, as it describes the testing and comparison of a physical medical device (a wheelchair) rather than a diagnostic AI algorithm.
However, I can extract the acceptance criteria as indicated by compliance with various ISO standards and the 'reported device performance' based on the comparison table and the general statements about meeting requirements.
Here's the closest representation of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Material Safety (Biocompatibility) | 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 | All user directly contacting materials are compliant with these ISO requirements, and tested to be safe. |
| Safety - Electromagnetic Compatibility (EMC) | IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests ISO7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters | Meets IEC 60601-1-2 and ISO7176-21 requirements. |
| Performance (General) | ISO 7176 series (including specific parts for stability, brakes, energy consumption, dimensions, speed, strength, climatic tests, obstacle climbing, power/control systems, batteries/chargers, etc.) ISO 16840-10: Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method FDA Guidance: Submission for Power Wheelchair Risk Analysis developed in accordance with ISO 14971: 2019 Software validation | The device complies with all referenced ISO standards and FDA guidance. All tests indicate a positive conclusion and meet requirements. |
| Braking Distance | ≤1.5 m (as per predicate) | ≤1.5 m |
| Maximum Safe Operational Incline Degree | 6° (as per predicate) | 6° |
| Max Loading Weight | 120kg (predicate), validated with maximum rated weight dummy. | 136kg (similar performance to predicate, validated with maximum rated weight dummy) |
| Max Speed Forward | Up to 6 km/h (1.6 m/s) adjustable (predicate) | Up to 5.4km/h (1.5m/s) (similar) |
| Max Speed Backward | Less than 3 km/h (0.8 m/s) (predicate) | Less than 2.5km/h (0.7m/s) (similar) |
| Maximum Distance of Travel on Fully Charged Battery | 16km (predicate) | 12km (similar, not causing new safety/effectiveness concerns) |
| Electronic Controller Performance | Meets the requirements of ISO 7176-14 | Meets the requirements of ISO 7176-14 |
| Brake System Effectiveness | Meets the requirements of ISO 7176-3 | Meets the requirements of ISO 7176-3 |
| Stability (Static, Dynamic) | Meets the requirements of ISO 7176-1 and ISO 7176-2 | Meets the requirements of ISO 7176-1 and ISO 7176-2 |
| Strength (Static, Impact, Fatigue) | Meets the requirements of ISO 7176-8 | Meets the requirements of ISO 7176-8 |
| Obstacle Climbing Ability | Meets the requirements of ISO 7176-10 | Meets the requirements of ISO 7176-10 (e.g., 25mm climbing vs predicate's 40mm, deemed not to cause new concerns) |
| Batteries and Chargers | Meets the requirements of ISO 7176-25 | Meets the requirements of ISO 7176-25 |
| Information Disclosure, Documentation, Labeling | Meets the requirements of ISO 7176-15 and FDA Regulatory | Conforms to ISO 7176-15 and FDA Regulatory |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" in terms of patient data or case numbers. Instead, it refers to performance and safety testing of the physical device according to various international standards (ISO). For tests involving a dummy, it mentions validation "with the maximum rated weight dummy." The number of devices tested is not explicitly stated.
- Data Provenance: The testing appears to have been conducted as part of the device development and verification process by the manufacturer in China. The specific location or date of individual tests are not detailed beyond the document preparation date (2025/2/26). The studies are inherently "prospective" in the sense that they are conducted to verify the new device's compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable. The device is an electrically powered wheelchair, not an AI diagnostic algorithm or system requiring expert-established ground truth from medical images or patient data. The "ground truth" for the device's performance is established by its compliance with engineering and safety standards, which are defined by standard bodies (like ISO) and regulatory bodies (like FDA), and verified through physical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies to resolve discrepancies among multiple expert readers for diagnostic tasks. For a physical device like a wheelchair, performance is measured against objective engineering and safety standards, not subjective expert assessment of a diagnostic outcome.
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:
- This section is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This document is for a physical medical device (a wheelchair) and does not involve AI for diagnostic purposes or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This section is not applicable. There is no AI algorithm being evaluated for standalone performance in this document. The device is a physical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is defined by the technical specifications, requirements, and acceptable tolerances outlined in the referenced international standards (e.g., ISO 7176 series, ISO 10993 series, IEC 60601-1-2) which are based on engineering principles, safety considerations, and recognized testing methodologies. It's essentially engineering and safety standard compliance verified through objective physical testing.
8. The sample size for the training set:
- This information is not applicable as this document does not describe the development or testing of an AI model with a training set.
9. How the ground truth for the training set was established:
- This information is not applicable as this document does not describe the development or testing of an AI model with a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2025
Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K244003
Trade/Device Name: Electrically powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 3, 2025 Received: February 26, 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.
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Page
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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory
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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,
Tushar Bansal -S
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Electrically powered wheelchair
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)
X 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:
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510(K) Summary K244003
Document Prepared Date: 2025/2/26
Applicant A.
Kunshan Hi-Fortune Health Products Co., Ltd Address:NO.625 Juxiang Road, Zhangpu Town,Kunshan City, Jiangsu, 215321, CHINA Contact Person: zhanli.Tian Email:zhanli.tian@hi-fortune.net
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: Eva Li 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: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP330
Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
Predicate device C.
510Knumber: K240105 Device Name:Navigator, Navigator XL
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Company:Forcemech International LLC
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.
ші Device Description:
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The entire wheelchair can be disassembled, making it easy to carry. The wheelchair comes equipped with an electronically controlled rising seat that allows the user 280mm/11" of seat height adjustment using the joystick.
The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid Battery as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon steel. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 136KG. Only for one person sit.
ட் Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Proposed Device | Predicate Device(K240105) | Remark |
|---|---|---|---|
| Manufacturer | Kunshan Hi-Fortune HealthProducts Co., Ltd | Forcemech International LLC | -- |
| Common or Usual name | Electrically poweredwheelchair | Power wheelchair | -- |
| Model(s) | HP330 | FMNVG15, FMNVX06 | -- |
| Classification | Class II | Class II | Same |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | Same |
| Product code | ITI | ITI | Same |
| Indications for use | It is a motor driven,indoor and outdoortransportation vehiclewith the intended use toprovide mobility to adisabled or elderly | It is a motor driven,indoor and outdoortransportation vehiclewith the intended use toprovide mobility to adisabled or elderly | S.E. |
| person limited to aseated position. | person limited to aseated position. | ||
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 4,including two front wheels and two rear Wheels | S.E |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheelsto control the speed and Direction | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheelsto control the speed and direction | S.E |
| Movement controlmethod | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rearwheels | Direct drive on the rearwheels | S.E |
| Brake system | Automatic electromagneticbrake system | Automatic electromagneticbrake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | S.E |
| Armrest | Polyurethane | Polyurethane | S.E |
| Max loading weight | 136kg | 120kg | Similar,All safety andperformance havebeen validated withthe maximum ratedweight dummy. |
| Maximum safeoperational inclinedegree | 6° | 6° | S.E |
| Back cushion | Polyurethane | Polyurethane | S.E |
| Seat cushion | Polyurethane | Polyurethane | S.E |
| Main frame material | Carbon steel material | Aluminum Alloy | Similar,Differentmaterials will notaffect safety andperformance of thesubject device as allrelated stability testsare performedaccording tostandard ISO 7176series |
| Overall Dimension(lengthwidthheight) | 950mm660mm950mm | Navigator FMNVG15 Model:980600940mmNavigator XL FMNVX06Model: 980620940mm | Minor difference onwheelchairdimension will notcause differentperformance. Allsafety and |
| Folded Dimension(lengthwidthheight) | 740mm600mm410mm | 590mm370mm787mm | performance havebeen validated withthe maximum ratedweight dummy. |
| Front wheel size/type | 6" PU Solid tire | 8" (203mm)Non-Pneumatic tire | Different sizes andmaterials will notaffect safety and |
| Rear wheel size/type | 10"PU Solid tires | 11.8" (300mm) Non-Pneumatic tire | performance of thesubject device as allrelated stability testsare performedaccording tostandard ISO 7176series. |
| Max speed forward | Up to 5.4km/h (1.5m/s) | Up to 6 km/h (1.6 m/s)adjustable | Similar |
| Max Speed backward | Less than 2.5km/h (0.7m/s) | Less than 3 km/h (0.8 m/s) | Similar |
| Maximum distance oftravel on the fullycharged battery | 12km | 16km | Similar , it will notcause new safetyand effectivenessconcerns. |
| Battery | Lead-acidBattery; rechargeable;12V 22AH | Li-ion batterypack; rechargeable, 24 VDC6Ah*2 | Both meet therequirements of the |
| Battery charger | Off-board chargerInput:100-240VAC,50-60Hz, 1.2-0.5AOutput:24V,2A | off-board chargerInput: 100-240V. 50/60Hz,1.5A.Output: 24 VDC. 2A | ISO 7176-25.It willnot cause new safetyand effectivenessconcerns. |
| Motor | Brushless DC motor;24VDC; 250W;2pcs | Brushless DC motor;24VDC; 250W;2pcs | S.E |
| Electronic controller | Dynamic,DLX-REM210-A,24V | Dual Core Twin Drivecontroller | Both meet therequirements of theISO 7176-14.It willnot cause new safetyand effectivenessconcerns. |
| Turning Radius | 825mm | 1200mm | Minor difference inturning radius iscaused by differentsize of wheelchairand may |
| Min obstacleclimbing | 25mm | 40mm | Minor difference onobstacle climbing willnot cause new safetyand effectiveness |
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| concerns. | |||
|---|---|---|---|
Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5、ISO10993-10 and ISO10993-23requirements. | All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements. | SE |
| EMC | IEC 60601-1-2&ISO7176-21 | IEC 60601-1-2&ISO7176-21 | SE |
| Performance | ISO7176 series | ISO7176 series | SE |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
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, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.
The indications for use for both devices are the same. 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.
The frame materials,Turning radius, Maximum obstacle climbing and Maximum loading weight 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 7176-8,ISO 7176-10 and ISO 7176-11.
The biocompatibility of the predicate device and proposed device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
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
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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
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.
l. 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).