(51 days)
Not Found
No
The description focuses on mechanical and electrical components and standard control mechanisms (joystick). There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No
The device is a transportation vehicle designed to provide mobility for disabled or elderly individuals, not to treat or diagnose a medical condition.
No
The device is described as a motor-driven indoor and outdoor transportation vehicle for mobility, not to diagnose any condition.
No
The device description clearly outlines numerous hardware components including a frame, wheels, seat, armrest, battery, motor, and controller. It is a physical transportation vehicle.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with components like a frame, wheels, motor, and battery. These are all related to physical movement and support, not to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro analysis.
- Performance Studies: The performance studies focus on safety, software validation, and compliance with standards related to wheelchairs and medical electrical equipment, not on diagnostic accuracy or analytical performance.
In summary, the device is clearly described as a mobility aid, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. 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 lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is Magnesium alloy. 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 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 120KG. Only for one person sit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
disabled or elderly person
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product Material Safety: Biocompatibility testing was done according to ISO10993-5, ISO 10993-10, and ISO 10993-23. The test results indicate the material is safe and meets requirements.
Performance of the products:
Risk Analysis developed in accordance with ISO 14971: 2019.
Software validation was performed.
Performance data was provided to verify the subject device met design specifications and supported substantial equivalence determination, including testing against multiple ISO 7176 series 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 7176-21, ISO 7176-22, ISO 7176-25), ISO 16840-10, and IEC 60601-1-2:2020. Key results indicate that the design principles of the controller and driving system are the same as the predicate, meeting ISO 7176-14 requirements. Brake system and speed control are also designed similarly, meeting ISO 7176-3. Minor differences in turning radius, maximum obstacle climbing, and maximum safe operational incline do not impact safety or effectiveness, as both meet ISO 7176-2 and ISO 7176-10. Electrical safety (EMC) was tested according to ISO7176-21 & IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue, with the word "FDA" in a square.
February 12, 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: K243962
Trade/Device Name: Electrically Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 20, 2024 Received: December 23, 2024
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,
Image /page/2/Picture/3 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and stands out against a white background. The letters are evenly spaced and easy to read. The overall impression is clean and professional.
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
Enclosure
3
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:
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."
4
Kunshan Hi-Fortune Health Products Co., Ltd. No.625 Juxiang Road zhangpu town , Kunshan City ,Jiangsu Province, China
510(K) Summary K243962
Document Prepared Date: 2025/02/11
A. Applicant
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: 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
Device B.
Trade Name: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP558
Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
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C. Predicate device
K212503 Electrically powered wheelchair,HP458E Kunshan Hi-Fortune Health Products Co., Ltd.
D. Indications for use of the device
lt 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.
ய் Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. 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 lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is Magnesium alloy. 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 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 120KG. Only for one person sit.
F. Comparison to predicate device
a) There are three changes to the proposed device:
| changes | Proposed Device | Predicate Device (K212503) |
|---|---|---|
| 1.Change Motor | DC Brushless Motor, | |
| 24Vdc 170W;2pcs | DC Brush Motor, | |
| 24Vdc 120W;2pcs | ||
| 2. Change controller | M7084 | PG Drives Technology Ltd., VR2 |
| 3. Change the Main frame | ||
| material size | Magnesium alloy | Aluminium alloy |
Technical comparison b)
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Table 1 General Comparison
| Elements of
Comparison | Proposed
Device(K243962) | Predicate Device
(K212503) | Remark |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kunshan Hi-Fortune
Health Products Co.,
Ltd | Kunshan Hi-Fortune
Health Products Co., Ltd | -- |
| Common or
Usual name | Electrically powered
wheelchair | Electric wheelchair | -- |
| Model(s) | HP558 | HP458E | -- |
| 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 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 | 6, including two
front wheels and
two rear
wheels, two anti-
tip wheels | 6, including two
front wheels and
two rear wheels,
two anti-tip wheels | Same |
| Function of
wheels | Front wheels:
driven wheels
suitable for
rotation,a
cceleratio
n,
retrograde | Front wheels:
driven wheels
suitable for
rotation,acce
leration,
retrograde
Rear wheels: driving | Same |
| | 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 | wheels
to control the speed and
direction
Anti-tip wheels:
preventing the
wheelchair from
tipping turning over
when driving on the
slope. Non-
adjustable | |
| Product
structure | Consists of two
foldable armrests, a
backrest, a seat
cushion, a foldable
frame, two rear
driving wheels with
hub
motor/electromagnet
ic brake assemblies,
two pivoting casters,
a Li-ion batteries, an
off-board battery
charger, a control
panel,
and an electric motor
controller | Consists of two foldable
armrests, a backrest, a
seat cushion, a foldable
frame, two rear driving
wheels with
hub
motor/electromagnetic
brake
assemblies, two pivoting
casters, a Li-ion
batteries, an off-board
battery charger, a
control panel,
and an electric motor
controller | Same |
| Movement
co
ntrol
method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the
rear
wheels | Direct drive on the rear
wheels | Same |
| Brake system | Automatic
electromagnetic
brake system | Automatic
electromagnetic
brake system | Same |
| Armrest | PU | PU | Same |
| Back cushion | Terylen
(polyester fabrics) | Terylene | Same |
| Seat cushion | Terylene
(polyester fabrics) | Terylene | Same |
| Main frame
material | Magnesium alloy | Aluminium alloy | Different |
| Max loading
weight | 120Kg | 264lbs(120Kg) | Same |
| Min
obstacle
climbing | 35mm | 50mm | Minor difference will not
cause different performance. |
| Total mass | 18KG | 41.9lbs/19KG | Similar |
| Overall
Dimension
(lengthwidth
height) | 1100mmX600mmX9
40mm
(43.3" × 23.6″ ×
37.0") | 39.0" × 24.4" × 34.6" | Similar |
| Folded
Dimension
(lengthwidth
height) | 690mmX380mmX72
0mm
(27.0" X 15.0" X
28.3") | 28.3" × 13.4" × 28.0" | Minor difference will not
cause different performance. |
| Front wheel
size/type | 5.5" PU tire | 6" PU tire | Similar |
| Rear wheel
size/type | 9.5" PU tires | 10" PU tires | Similar |
| Max speed
forward | 5.0km/h(1.4m/s) | 6km/h | Similar |
| Max speed
backward | 2.88km/h(0.8m/s) | 2.88km/h | Same |
| Static stability | Forward:20.0°
Rear ward:17.0°
Sideways:19.2° | Forward:16.5°
Rear ward:16.5°
Sideways:17° | Minor difference on safe
operational incline degree
will not cause new safety and
effectiveness concerns, as
both the static and dynamic
stability under specific
inclining degree have been
evaluated according to |
| Maximum safe operational in | 10° | 6° | Minor difference on safe
operational incline degree
will not cause new safety and
effectiveness concerns, as
both the static and dynamic
stability under specific
inclining degree have been
evaluated according to |
| cline
degree | | | standard ISO 7176 series. |
| Braking distance | 1.1m | 1 m | Minor difference on braking distance will not cause different performance.
Shorter distance for braking will be more safety. |
| Maximum
distance of
travel on the
fully charged
battery | 12.6km | 15km | Minor difference will not cause different performance. |
| Min.Turning
Radius | 900mm | 1000mm | Minor difference in turning radius is caused by different size of wheelchair ,it will not cause different performance. |
| Battery | li-ion battery pack;rechargeable,
25.2VDC,
10.4Ah,2pcs | li-ion battery pack;rechargeable,
25.2VDC, 10.4Ah,2pcs | Same |
| Battery
charger | High Power TechnologyInc.
HP0060W(L2)
Input: 100-240 VAC
Output: DC 24V, 2 Amp | High Power TechnologyInc.
HP0060W(L2)
Input: 100-240 VAC
Output: DC 24V, 2 Amp | Same |
| Motor | DC Brushless Motor,
24Vdc 170W;2pcs | DC Brush Motor,
24Vdc 120W;2pcs | Analysis,The design principles of the controller and Driving system are the same, and both |
| controller | M7084 | PG Drives Technology
Ltd., VR2 | meet the requirements of the ISO 7176-14:2008. Software validation is carried out on
both control systems. |
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8
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Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5、 | |||
| ISO10993-10 and ISO10993-23 | |||
| requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| ISO10993-10 requirements. | SE | ||
| EMC | ISO7176-21& IEC 60601-1-2 | ISO7176-21 | SE |
| Performance | ISO7176 series | ISO7176 series | SE |
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| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
|---|---|---|---|
| -------------------- | ---------------------------- | ---------------------------- | ---- |
Substantial Equivalence Discussion G.
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 ,controller and main frame appearance and materials.
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 main frame is not in contact with human tissue, and the material difference does not cause a security risk.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.
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
2.1 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
11
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.
2.2 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
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Conclusion -
The subject device and the predicate products 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.