(149 days)
No
The description focuses on standard power wheelchair components and control mechanisms (joystick, remote control via BLE, electromagnetic brakes). There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration.
No
A therapeutic device is typically used to treat a disease or condition. A power wheelchair is a mobility aid, designed to provide transportation and enhance independence for individuals with limited mobility, but it does not treat a specific condition or disease.
No
The intended use of the power wheelchair is to provide mobility to a disabled or elderly person, not to diagnose a medical condition.
No
The device description clearly outlines numerous hardware components including motors, brakes, battery, frame, wheels, and a physical joystick. While it includes software for control and remote operation, it is fundamentally a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Intended Use: The intended use of this device is clearly stated as providing mobility to disabled or elderly persons. It is a transportation vehicle.
- Device Description: The description details the mechanical and electrical components of a wheelchair, not equipment for analyzing biological samples.
- Lack of Relevant Information: The document does not mention any testing of biological samples, analysis of bodily fluids, or any other activity related to in vitro diagnostics.
This device is a mobility aid, specifically a power wheelchair.
N/A
Intended Use / Indications 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 codes
ITI
Device Description
The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.
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
Not Found
Intended User / Care Setting
disabled or elderly person limited to a seated position / indoor and outdoor use
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)
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 - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
- Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021).
Key results: 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, The Dynamic stability, 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. 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 cybersecurity has been validated to be effective and do not raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 27, 2024
Anhui JBH Medical Apparatus Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1 401 , Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K242252
Trade/Device Name: Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 25, 2024 Received: November 25, 2024
Dear Ivy Wang:
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
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 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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Power Wheelchair
Indications for Use (Describe)
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.
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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4
510(k) Summary
K242252
l. SUBMITTER
Name: Anhui JBH Medical Apparatus Co., Ltd.
Address: No. 116 Qicang Road, Industrial District, Ming Guang City, Chuzhou, Anhui, China
Name of contact person: Wei Yuanwei
Telephone: +86-0550-8108866
Fax: +86-0550-8106688
Email: +86-0550-8106688
Date prepared: 2024-11-18
II. Device
Device trade name: Power wheelchair
Model: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
| III. | Predicate | device |
|---|---|---|
| ------ | ----------- | -------- |
| Predicate device | Reference device |
|---|---|
| K212092 | K223393 |
| Portable Folding Electric Wheelchair (Model: DC01) | Electric Wheelchair (Model: BBR-LY-01-01) |
| Anhui JBH Medical Apparatus Co., Ltd | Shanghai BangBang Robotics Co., Ltd. |
IV. Device description
The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive)
5
powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange
V. 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.
VI. Comparison of technological characteristics with the predicate device
6
General Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Manufacturer | Anhui JBH Medical Apparatus | |||
| Co., Ltd. | Anhui JBH Medical Apparatus | |||
| Co., Ltd. | Shanghai BangBang Robotics / | |||
| Co., Ltd. | / | |||
| Proprietary | ||||
| name, model | Power Wheelchair | |||
| DC01, DC02, DC03, DC05, | ||||
| DC06, DC07L, DC08L, DC09L, | ||||
| DC10L | power wheelchair, DC01 | Electric Wheelchair | ||
| (Model: BBR-LY-01-01) | / | |||
| 510(k) number | TBD | K212092 | K223393 | / |
| Device | ||||
| classification | ||||
| name | Class II | Class II | Class II | Same |
| Classification | ||||
| regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | ITI | Same |
| 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. | The wheelchair (Model: DC01) 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 intended use of the | |||
| Electric Wheelchair (Model: | ||||
| BBR-LY-01-01) is to provide | ||||
| outdoor and indoor mobility to | ||||
| persons limited to a seated | ||||
| position that are capable of | ||||
| operating a powered | ||||
| wheelchair. | Same | |||
| Intended user | disabled or elderly person | |||
| limited to a seated position | disabled or elderly person | |||
| limited to a seated position | disabled or elderly person | |||
| limited to a seated position | Same | |||
| Use condition | indoor and outdoor use | indoor and outdoor use | indoor and outdoor use | Same |
| Type of use | OTC | OTC | OTC | Same |
7
Basic Parameters Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Device length | 875mm – 1050mm | 875mm | 1075mm | Minor difference on |
| dimension do not affect | ||||
| safety and effectiveness. All | ||||
| safety and performance | ||||
| have been validated with | ||||
| the maximum rated weight | ||||
| dummy. | ||||
| Device Width | 757mm – 665mm | 620mm | 628mm | |
| Stowage Length | 575mm – 1013mm | 750mm | 895mm | |
| Stowage width | 280mm – 620mm | 400mm | 628mm | |
| Stowage height | 715mm -850mm | 800mm | 395mm | |
| Ground | ||||
| clearance | 40mm - 137mm | 100 mm | 64mm | Minor difference on ground |
| clearance do not affect | ||||
| effectiveness and safety | ||||
| performance. All safety and | ||||
| performance have been | ||||
| validated with the maximum | ||||
| rated weight dummy. | ||||
| Number of | ||||
| wheels | 4 | 4 | 4 | Same |
| Front wheel | ||||
| size/type | 7" /PU Solid tire | 7" /PU Solid tire | 10 in | larger size of driven wheel |
| will provide better stability | ||||
| Rear | ||||
| wheel | ||||
| size/type | 8" /PU Solid tire for DC01, | |||
| DC02, DC05, DC07L, | ||||
| DC08L, DC09L, DC10L | ||||
| 12" /PU Solid tire for DC03, | ||||
| DC06 | 8" /PU Solid tire | 10 in | and safety performance | |
| Function | ||||
| of | ||||
| wheels | Front wheels: driven wheels | |||
| suitable for rotation, | ||||
| acceleration, retrograde | ||||
| Rear wheels: driving wheels | ||||
| to control the speed and | ||||
| direction | Front wheels: driven wheels | |||
| suitable for rotation, | ||||
| acceleration, retrograde | ||||
| Rear wheels: driving wheels to | ||||
| control the speed and direction | Front wheels: driven wheels | |||
| suitable for rotation, | ||||
| acceleration, retrograde | ||||
| Rear wheels: driving wheels to | ||||
| control the speed and direction | Same | |||
| Frame design | The frame of the wheelchair | |||
| is type capable of front and | ||||
| rear close. The main part of | ||||
| the frame can be folded for | ||||
| saving space and convenient | ||||
| storage and transportation. | The frame of the wheelchair is | |||
| type capable of front and rear | ||||
| close. The main part of the | ||||
| frame can be folded for saving | ||||
| space and convenient storage | ||||
| and transportation. | The frame of the wheelchair is | |||
| type capable of front and rear | ||||
| close. | Same | |||
| Folding | ||||
| mechanism | Manually fold/ expand | Manually fold/ expand | Automatically | |
| fold/ | ||||
| expand | ||||
| drove by motor | Same | |||
| Movement | ||||
| control method | By Joystick control and | |||
| Bluetooth remote controller | By Joystick control | By Joystick control and | ||
| Bluetooth smartphone app | ||||
| control | Same with reference | |||
| device, has one more | ||||
| control method through | ||||
| Bluetooth. | ||||
| Driving system | Direct drive on the rear | |||
| wheels | Direct drive on the rear wheels | Direct drive on the rear wheels | Same | |
| Brake system | Intelligent electromagnetic | |||
| brake system | Intelligent regenerative | |||
| Electromagnetic brake | Electromagnetic | Same | ||
| Max speed | ||||
| forward | Up to 6 km/h (3.75 mph), | |||
| continuously adjustable | Up to 6 km/h (3.75 mph), | |||
| variable | 6km/h | Same | ||
| Main frame | ||||
| material | Carbon fiber | Carbon fiber | Not applicable | Same |
| Armrest cushion | Polyurethane (PU) | Polyurethane (PU) | Not applicable | Same |
| Speed settings | 5 | 5 | 5 | Same |
| Differences | ||||
| Battery | li-ion battery; rechargeable, | |||
| 24 VDC 12Ah/ 6Ah*2 | Li-ion, Rechargeable; 24 VDC | |||
| 20Ah | 1 rechargeable | |||
| battery | ||||
| Ratings: 24 V 20Ah | lithium-ion Same rated voltage with | |||
| different power capacity, | ||||
| both batteries are tested | ||||
| according to IEC62133-2, | ||||
| this difference will not affect | ||||
| the safety and performance | ||||
| of the subject device. | ||||
| Maximum | ||||
| distance of travel | ||||
| on the fully | ||||
| charged battery | 23 km for model DC06 | |||
| 20 km for model DC01, | ||||
| DC02, DC03, DC05, DC07L, | ||||
| DC08L, DC09L, DC10L | 20 km | 20.6 km | Minor difference on travel | |
| distance will not cause | ||||
| different performance. This | ||||
| difference will not raise any | ||||
| new safety and | ||||
| effectiveness concerns. | ||||
| Battery charger | Off-board charger | Off-board charger | Input: 100-240VAC | |
| 50-60Hz 1.9A | ||||
| Output: 24V 4A | More wide range of input | |||
| voltage in the device which | ||||
| will not cause new safety | ||||
| and effectiveness concerns | ||||
| raised. | ||||
| Input: 100-240Vac, 50/60Hz, | ||||
| 1.5A | ||||
| Output: 24 Vdc, 2A | ||||
| For models DC01, DC02, | ||||
| DC03, DC05, DC06 | ||||
| Input: 100V- 240Vac, | ||||
| 50/60Hz, 1.7A | ||||
| Output: DC 29.4V, 2A | ||||
| For models DC07L, DC08L, | ||||
| DC09L, DC10L | Input: 100-240V, 50/60Hz, 1.5A | |||
| Output: 24 Vdc, 2A | ||||
| Minimum braking | ||||
| distance from | ||||
| maximum speed | Forward: Performance testing-bench |
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.
16
- . ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method.
- . ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
Biocompatibility of patient-contacting material A
Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021). Details of the test summary see biocompatibility summary.
IX. 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.
X. Conclusions
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K212092.