(51 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 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 leftright motor to realize the wheelchair forward, backward and turn functions. The frame of the device is aluminum alloy. The front 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.
The provided document is a 510(k) Premarket Notification for an Electrically Powered Wheelchair (HP206). It primarily details the device's characteristics and compares it to a predicate device (HP358EA) to demonstrate substantial equivalence.
However, the document does not contain information about a study proving device performance against specific acceptance criteria, especially not in the context of an AI/human reader study as typically associated with the comprehensive questions asked. The device in question is an Electrically Powered Wheelchair, not a medical imaging or diagnostic AI device that would involve expert readers, ground truth establishment for a test set, multi-reader multi-case studies, or AI algorithm performance metrics like sensitivity, specificity, etc.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the device's compliance with established performance standards and safety requirements for electrically powered wheelchairs.
Therefore, I cannot populate the requested table or answer most of the specific questions about AI performance, expert adjudication, or MRMC studies for this device, as these concepts are not applicable to the information provided in the 510(k) submission for a powered wheelchair.
I can, however, extract the performance data and compliance standards mentioned:
1. Table of acceptance criteria and the reported device performance
The document frames "acceptance criteria" as compliance with various ISO standards and FDA guidance. "Reported device performance" is demonstrated through testing against these standards. There isn't a specific quantitative "acceptance criteria" table with corresponding numerical "reported performance" easily extractable for each parameter the way one would for an AI diagnostic device. Instead, the document states that the device "met all design specifications" and provided "support of the substantial equivalence determination" by undergoing the listed tests.
Here's an attempt to structure it based on the available information, understanding that "acceptance criteria" is implied by compliance with the standards, and "reported performance" is that it passed the tests:
| Acceptance Criterion (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 10993-5 (In Vitro cytotoxicity) | Met requirements; material is safe |
| ISO 10993-10 (Skin sensitization) | Met requirements; material is safe |
| ISO 10993-23 (Irritation) | Met requirements; material is safe |
| ISO 14971:2019 (Risk Analysis) | Risk Analysis developed in accordance. |
| Software validation | Software validation carried out and meets requirements. |
| ISO 7176-1:2014 (Static stability) | Compliance stated (implied by "met all design specifications" and "positive conclusion") |
| ISO 7176-2:2017 (Dynamic stability) | Compliance stated |
| ISO 7176-3:2012 (Brake effectiveness) | Compliance stated; meets ISO 7176-3 |
| ISO 7176-4:2008 (Energy consumption) | Compliance stated |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering) | Compliance stated |
| ISO 7176-6:2018 (Max speed, acceleration) | Compliance stated |
| ISO 7176-7:1998 (Seating & wheel dimensions) | Compliance stated |
| ISO 7176-8:2014 (Static, impact, fatigue strength) | Compliance stated |
| ISO 7176-9:2009 (Climatic tests) | Compliance stated |
| ISO 7176-10:2008 (Obstacle-climbing) | Compliance stated; meets ISO 7176-10 |
| ISO 7176-11:2012 (Test dummies) | Compliance stated |
| ISO 7176-13:1989 (Coefficient of friction) | Compliance stated |
| ISO 7176-14:2022 (Power & control systems) | Compliance stated; meets ISO 7176-14 |
| ISO 7176-15:1996 (Information & labeling) | Compliance stated |
| ISO 16840-10:2021 (Resistance to ignition) | Compliance stated; test carried out according to standard |
| ISO 7176-21:2009 (EMC) | Compliance stated; IEC 60601-1-2 & ISO7176-21 |
| ISO 7176-22:2014 (Set-up procedures) | Compliance stated |
| ISO 7176-25:2013 (Batteries & chargers) | Compliance stated |
| IEC 60601-1-2:2020 (EMC) | Compliance stated |
| FDA Regulatory Guidance (Label and labeling) | Conforms to FDA Regulatory |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "sample size" in the conventional sense for a clinical trial or algorithm test set with individual cases. The testing refers to the device prototype(s) themselves. For mechanical and electrical performance tests, a limited number of test units (often 1-3) are typically used per test type, depending on the standard. For biocompatibility, material samples are tested.
- Data Provenance: The tests are performed to demonstrate compliance with international standards (ISO, IEC) generally by test labs. The document does not specify geographical provenance for the testing data in terms of "country of origin of the data" being retrospective or prospective from patient cohorts. It's device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to an electrically powered wheelchair device. "Ground truth" in this context would refer to the physical and electrical safety and performance parameters measured against established engineering and medical device standards. No "experts" are establishing "ground truth" in the diagnostic sense. Compliance is verified by testing according to published, objective standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to consensus reading for diagnostic purposes, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on established international performance and safety standards (ISO and IEC, as listed in the document) and FDA guidance for electrically powered wheelchairs. Compliance is demonstrated through physical, electrical, and materials testing.
8. The sample size for the training set:
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established:
- Not applicable.
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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 depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym 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: K243961
Trade/Device Name: Electrically Powered Wheelchair (HP206) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 23, 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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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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Electrically Powered Wheelchair (HP206)
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)
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Kunshan Hi-Fortune Health Products Co., Ltd. No.625 Juxiang Road zhangpu town , Kunshan City Jiangsu Province, China
510(K) Summary K243961
Document Prepared Date: 2025/2/11
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
B. Device
Trade Name: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP206
Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
C. Predicate device
510Knumber: K211647 Device Name:Electrically Powered Wheelchair Modesl:HP358EA Kunshan Hi-Fortune Health Products Co., Ltd.
D. Indications for use of the device
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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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 leftright motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is aluminum alloy. The front 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 with predicate Device
Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table:
| changes | Proposed Device | Predicate Device (K211647) |
|---|---|---|
| 1.Change Motor type | DC Brushless Motor,24Vdc 170W;2pcs | DC Brush Motor,24Vdc 250W;2pcs |
| 2. Change controller model | M7084 | PG D51492 |
a) There are two changes to the proposed device:
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Kunshan Hi-Fortune Health Products Co., Ltd. No.625 Juxiang Road zhangpu town , Kunshan City Jiangsu Province, China
b) Technical comparison
Table 1 General Comparison
| Elements ofComparison | Proposed Device | Predicate Device (K211647) | Remark |
|---|---|---|---|
| Manufacturer | Kunshan Hi-Fortune HealthProducts Co., Ltd | Kunshan Hi-Fortune HealthProducts Co., Ltd | -- |
| Common or Usual name | Electrically poweredwheelchair | Electrically Powered Wheelchair | -- |
| Model(s) | HP206 | HP358EA | -- |
| Classification | Class II | Class II | S.E. |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | S.E. |
| Product code | ITI | ITI | S.E. |
| 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. | S.E. |
| 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 | 6, including two front wheels and two rear wheels, two anti-tip wheels | S.E. |
| Function of wheels | Front wheels: drivenwheels suitable forrotation, acceleration, retrogradeRear wheels: driving wheelsto control the speed anddirectionAnti-tip wheels: preventingthe wheelchair fromtipping turning over whendriving on the slope. Non-adjustable | Front wheels: driven wheelssuitable forrotation, acceleration,retrogradeRear wheels: driving wheelsto control the speed anddirectionAnti-tip wheels: preventing thewheelchair from tipping turningover when driving on the slope.Non-adjustable | 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. |
| Armrest | PU | PU | S.E. |
| Back cushion | Terylene | Terylene | S.E. |
| Seat cushion | Terylene | Terylene | S.E. |
| Main frame material | Aluminum alloy | Aluminum alloy | S.E. |
| Max loading weight | 120KG | 120KG | S.E. |
| Maximum obstacleclimbing | 35mm | 30mm | Similar,Minor difference will not cause differentperformance. |
| Total mass | 22KG | 22KG | S.E. |
| Overall Dimension(lengthwidthheight) | 950mmX660mmX940mm | 990mmX620mmX940mm | Similar,Minor difference on wheelchair dimensionwill not cause different performance.All safety and performance have beenvalidated with the maximum rated weightdummy. |
| Folded Dimension(lengthwidthheight) | 660mmX420mmX720mm | 620mmX550mmX850mm | S.E. |
| Front wheel size/type | 8" PU tire | 8" PU tire | S.E. |
| Rear wheel size/type | 12" PU tires | 12" Pneumatic tires | Similar,Minor difference will not causedifferent performance. |
| Max speed forward | 1.5 m/s | 1.4 m/s | Similar |
| Max Speed backward | 0.9m/s | 0.8m/s | S.E. |
| Maximum safeoperational inclineDegree | 10° | 10° | S.E. |
| Maximum Brakingdistance | Forwards 1.2m;Reverse 0.6m | Forwards 0.8m;Reverse 0.6m | Similar |
| Maximum distance oftravel on the fullycharged battery | 10.6km | 10km | Minor difference will not cause differentperformance. |
| Turning Radius | 750mm | 500mm | Minor difference will not cause differentperformance. |
| Battery | li-ion battery pack;rechargeable,25.2VDC,10.4Ah | li-ion battery;rechargeable, 25.2VDC, 10.4Ah | S.E |
| Battery charger | Off-board charger,Input :100-240VAC, | Off-board charger,Input : 100-240VAC, 50-60Hz, 1.2-0.5A | S.E |
| 50-60Hz, 1.2-0.5ADC output: 24Vdc 2A | DC output: 24Vdc2A | ||
| Motor | DC Brushless Motor,24Vdc 170W;2pcs | DC Brush Motor,24Vdc 250W;2pcs | Analysis, The design principles of thecontroller and Driving system are the |
| controller | M7084,24V 35A | PG D51492,24V 35A | same, and both meet the requirements ofthe ISO 7176-14:2008. Software validationis carried out on both control systems. |
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Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials arecompliance with ISO10993-5、ISO10993-10 and ISO10993-23requirements. | All user directly contacting materials arecompliance with ISO10993-5 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 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-22,ISO 7176-25, IEC 60601-1-2 and FDA guidance Submission for Power Wheelchair.
The indications for use, design, structure, composition and energy source of proposed device and predicate device are identical.The dimensions and performance parameters are similar.The main differences are motor and controller.
The design principles of the controller and Driving system are the requirements of the ISO 7176-
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- Software validation is carried out on both control systems. Brake system and speed control are same way as well, and both meet 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 ISO 7176-2 and ISO 7176-10.
The materials in contact with human tissue are identical for both proposed device and predicate device. The biocompatibility of the proposed device and predicate device meet the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
The flame-retardant test of the seat cyshion/ backrest of both subject device is carried out acording 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
- c) Product Material Safety
To ensure the safety of the wheelchair material, the bio-compatibility testing was done to the testing was conducted according to the following standards:
ISO 10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
From the test result, we can find the material are safety and can meet the requirements.
- d) 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
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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 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 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 procedures
ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs.
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020 8.11.
1. Conclusion
The proposed device and predicate 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 essentially equivalent.
N/A