(105 days)
Not Found
No
The description details a standard electric wheelchair with manual joystick control and basic speed adjustments. There is no mention of any features that would suggest AI or ML capabilities, such as autonomous navigation, obstacle detection with intelligent response, or adaptive control based on user patterns. The performance studies listed are standard safety and performance tests for wheelchairs, not AI/ML validation.
Yes
The device is intended to provide mobility to disabled or elderly individuals, which addresses a health-related condition, and it falls under the classification of a Class I device (electric wheelchair, pred. K192739).
No
Explanation: The device is an electric wheelchair designed to provide mobility. It does not perform any diagnostic functions or provide information used to diagnose a medical condition.
No
The device description explicitly details numerous hardware components including a motor, battery, frame, wheels, joystick, and controller, indicating it is a physical device with integrated software for control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to disabled or elderly individuals. This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details the components and function of an electric wheelchair, which is a mobility aid. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a Class II medical device intended for mobility assistance, as evidenced by the predicate device and the standards it was tested against (which are related to wheelchairs and mobility aids).
N/A
Intended Use / Indications for Use
The electric wheelchair (Model: DH01108 (2)) is a motor driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
Product codes
ITI
Device Description
The proposed device, Electric Wheelchair , mainly powered by rechargeable battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, controller, battery pack, motor rear wheel, footplate, seat cushion, back cushion, handle.
The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.This wheelchair is suitable for the user who with weight less than 100kg.
The device is folding design. This foldable electric wheelchair has front frame, backrest frame,armrest. The wheelchair can be easily folded, when folding the wheelchair, turn over the armrest successively.
Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light.
Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward.
The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key.
Frame design: overall size: 905999cm, net weight: 22kg
The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.
The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.
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
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)
The Electrical Wheelchair has been evaluated the safety and performance by lab bench testing according to the following standards:
- EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
- ISO 7176-1: 2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2: 2017 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered 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 overall dimensions, mass and manoeuving 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 strengths
- 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: 2008 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 7176-16: 2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25: 2013Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications-part 2: Lithium systems
- ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- IEC 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for safety Collateral . standard: Electromagnetic compatibility - Requirements and tests
- ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the Electric Wheelchair to its predicate device.
Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that DH01108 (2) Electric Wheelchair is substantially equivalent to the legally marketed predicate device.
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).
0
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.
July 5, 2022
Foshan Dahao Medical Technology Co.,Ltd % Iris Fung Regulation Manager Guangdong Jianda Medical Technology Co., Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong 510000 China
Re: K220827
Trade/Device Name: Electric Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 18, 2022 Received: March 22, 2022
Dear Iris Fung:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/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,
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
2
Indications for Use
510(k) Number (if known) K220827
Device Name Electric Wheelchair
Indications for Use (Describe)
The electric wheelchair (Model: DH01108(2)) is a motor driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an 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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.3860.
1. Submitter Information
Sponsor Company Name: Foshan Dahao Medical Technology Co.,Ltd. Address: Building 1, 2nd floor of building 2, 3rd floor of building 3、4、5、6、7, No.9 of Fanye Road,Leping town,Sanshui District,Foshan City,Guangdong Province,528137,China Phone: +86-13760674304 Contact Person (including title): BaoYi Xie (Regulation Manager) E-mail: 709111267@qq.com
Application Correspondent: Guangdong Jianda Medical Technology Co Ltd. Address:906 Room, Longxiang Garden, Tianhe district, Guangzhou, China Contact Person:Ms. Iris Fung Tile: Regulation Manager Tel:+86- 13211147965 Email:mdc-fs@foxmail.com; jianda-lee@foxmail.com
2. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Powered Wheelchair Trade Name: Electric Wheelchair Classification Name: Powered Wheelchair Review Panel: Physical Medicine Product Code: ITI Requlation Number: 21 CFR 890.3860 Regulation Class: Class II
3. Predicate Device Information
Sponsor: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Common Name: Powered Wheelchair Trade Name: Electric Wheelchair 510(k) number: K192739
4
Review Panel: Physical Medicine Product Code: ITI Regulation Number: 21 CFR 890.3860 Regulation Class: Class II
4. Device Description
The proposed device, Electric Wheelchair , mainly powered by rechargeable battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, controller, battery pack, motor rear wheel, footplate, seat cushion, back cushion, handle.
The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.This wheelchair is suitable for the user who with weight less than 100kg.
The device is folding design. This foldable electric wheelchair has front frame, backrest frame,armrest. The wheelchair can be easily folded, when folding the wheelchair, turn over the armrest successively.
Controller : The controller includes a power key/speed adjustment key , a direction joystick and speed light ,battery capacity light.
Joystick: It is used to control the electric wheelchair drive direction and speed. The joystick pushes away in the same direction as the wheelchair moves forward.
The wheelchair also provided with max speed limit setting so that user can select the max speed level by the round key.
Frame design: overall size: 905999cm, net weight: 22kg
The operation mode of the folding mechanism is to remove the locking device by someone else and manually push the backrest frame to complete the folding operation under non-riding state.
The motor of electric wheelchair is DC24V 200W*2; Inner power is DC24, 10Ah; The charger of Lithium ion battery Input:AC 100-240V;50-60Hz;1.2-0.5A; output : DC 24V,2,0A.
5. Intended Use
The Electric Wheelchair (Model: DH01108 (2)) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
6. Test Summary of Non-clinical Testing
The Electrical Wheelchair has been evaluated the safety and performance by lab bench testing according to the following standards:
5
- . EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods
- . ISO 7176-1: 2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2: 2017 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered 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 overall dimensions, mass and manoeuving 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 strengths
- 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: 2008 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 7176-16: 2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- . ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25: 2013Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- . IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications-part 2: Lithium systems
EMC
- . ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
6
- IEC 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for safety Collateral . standard: Electromagnetic compatibility - Requirements and tests
Biocompatibility
The parts in contact with the user include: Joystick controller, is made of 80% Thermoplastic poly urethane elastomer rubber(TPU), 15%Fire retardant and 5% Fertilizer. Armrest and seat cushion are made of 100% polyurethane (PU) . All contact materials have passed biological tests and are harmless to humans. Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including :
- . ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
All contact materials have passed biological tests and are harmless to humans.
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use,
functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Foshan Dahao Medical Technology | ||
| Co.,Ltd. | JERRY MEDICAL INSTRUMENT | ||
| (SHANGHAI) CO., LTD. | -- | ||
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Electric Wheelchair | Electric Wheelchair | Same |
| 510 (k) | |||
| Number | K220827 | K192739 | -- |
| Models | DH01108 (2) | JRWD6010, JRWD6012 | -- |
| Intended Use | The Electric Wheelchair is a motor- | ||
| driven, and indoor transportation | |||
| vehicle with the intended use to | |||
| provide mobility to a disabled or an | |||
| elderly person limited to a seated | The device is a motor-driven, and | ||
| indoor transportation vehicle with the | |||
| intended use to provide mobility to a | |||
| disabled or an elderly person limited | |||
| to a seated position. | Same |
Table1 General Comparison
7
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| position. | |||
| Use | |||
| environment | Indoor use | Indoor use | Same |
| Patient | |||
| Population | The electric wheelchair is intended to | ||
| provide mobility to a person with a | |||
| disability or an older adult limited to | |||
| a sitting position | The electric wheelchair is intended to | ||
| provide mobility to a person with a | |||
| disability or an older adult limited to | |||
| a sitting position | Same | ||
| Product | |||
| structure | composed of front frame, rear frame, | ||
| backrest | |||
| frame, two foldable | |||
| armrests, two pivoting front wheel, | |||
| controller, lithium-ion battery pack, | |||
| two motor rear wheel,an off-board | |||
| battery charger, anti-roll wheel, | |||
| footplate, seat cushion, back cushion, | |||
| handle ,a 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 | ||
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of | |||
| wheels | 4 | 4 | Same |
| Main frame | |||
| material | Aluminium alloy | Aluminium alloy | Same |
| Motor | DC 24V*200W * 2pcs | DC24V* 180W*2pcs | Minor differences |
| in the dimensions | |||
| Battery | Lithium-ion 24V, 10AH,1pcs | DC 24V 20Ah Lithium-ion,1 pcs | will not |
| impact the safety | |||
| Battery charger | Input: 100-240VAC | ||
| output : DC 24V ,2.0Amp | High Power Technology Inc. | ||
| HP0180WL2 | |||
| Input: 100-240 VAC | |||
| Output: DC 24V, 6 Amp | and | ||
| effectiveness | |||
| of | |||
| the | |||
| substantial | |||
| equivalence. |
Table2 Performance Comparison
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| JRWD6010 | JRWD6012 | |||
| Manufacturer | Foshan Dahao Medical | |||
| Technology Co.,Ltd. | JERRY MEDICAL INSTRUMENT | |||
| (SHANGHAI) CO., LTD. | -- | |||
| Dimensions | 90cm x59cm x99cm | 38.1"x24.0"x37.0" | 39.3"x23.6"x37.0" | Similar |
| Stowage | ||||
| dimensions | ||||
| (Length*width | ||||
| *height) | 53cmx38cm x40cm | 44cm x40cm | ||
| x46cm | 44cm x46cm | |||
| x46cm | Minor difference on | |||
| Stowage dimensions | ||||
| will not | ||||
| cause different | ||||
| performance as all | ||||
| performance tests are | ||||
| performed according to | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| JRWD6010 | JRWD6012 | |||
| Weight,w/ | ||||
| Battery | 48.5Ibs./22kg | 58.4 lbs./26.5kg | 58.2 lbs./26.4kg | standard ISO |
| 7176 series | ||||
| The difference will | ||||
| not raise any new safety | ||||
| and effectiveness | ||||
| concerns and will not | ||||
| affect the safety and | ||||
| effectiveness of the | ||||
| subject device. | ||||
| Frame design | Foldable / | |||
| The device consists of a foldable | ||||
| and non-rigid type of power | ||||
| wheelchair base with rear drive | ||||
| and 2 casters in the front and 2 | ||||
| anti-tippers in the rear. | Foldable / | |||
| The device consists of a foldable and | ||||
| non-rigid type of power wheelchair | ||||
| base with rear drive and 2 casters in the | ||||
| front and two anti-tippers in the rear. | Same | |||
| Folding | ||||
| mechanism | A foldable seat frames | |||
| (The backrest could be folded to | ||||
| seat) | A foldable seat frames | |||
| (The backrest could be folded to seat) | Same | |||
| Front wheel | ||||
| (inch ) | 6 | |||
| (PU solid tire) | 8 | |||
| (PU solid tire) | Smaller sizes of | |||
| wheels, The difference | ||||
| will not raise any new | ||||
| safety and effectiveness | ||||
| concerns. | ||||
| Rear tire | ||||
| (inch) | 8 | |||
| (PU solid tire) | 10 | |||
| (PU solid tire) | 12 | |||
| (Pneumatic tire) | will not raise any new | |||
| safety and effectiveness | ||||
| concerns. | ||||
| Cruising | ||||
| Range(km) | 10-25 | 20 | Actual Cruising | |
| Range varies depending | ||||
| on the rider's weight, | ||||
| environment and battery | ||||
| usage, this will not | ||||
| affect the safety and | ||||
| effectiveness of the | ||||
| subject device. | ||||
| Obstacle | ||||
| climbing(mm) | 25 | 50 | Subject Device has a | |
| lower obstacle climbing, | ||||
| but this will not affect | ||||
| the safety and | ||||
| effectiveness of the | ||||
| subject device. | ||||
| Max. Speed | ||||
| (km/h) | 5.4 | 6 | Subject Device has a | |
| smaller Max. speed, but | ||||
| this will not affect the | ||||
| use of the product | ||||
| function and safety. | ||||
| Static stability | ||||
| forward | ≥6° | 21.8° | Both of the devices are | |
| evaluated according to | ||||
| standard ISO 7176- | ||||
| 1:2014, so the different | ||||
| static stability will not | ||||
| impact the safety and | ||||
| effectiveness. | ||||
| Static stability | ||||
| rearward | ≥6° | 19° | standard ISO 7176- | |
| 1:2014, so the different | ||||
| static stability will not | ||||
| impact the safety and | ||||
| effectiveness. | ||||
| Static stability | ||||
| sideways | ≥6° | 19.2° | static stability will not | |
| impact the safety and | ||||
| effectiveness. | ||||
| Max. loading | ||||
| (kg) | 220lbs(100kg) | 220lbs (100kg) | Same | |
| Maximum | 9° | 10 degrees | Same | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | ||
| JRWD6010 | Predicate Device | |||
| JRWD6012 | Verdict | |||
| safe | ||||
| operational | ||||
| incline | ||||
| Min. Turning | ||||
| radium | 900mm | 1820mm | The difference in the | |
| tuming radius will bring | ||||
| more convenience when | ||||
| it turns.The difference | ||||
| will not raise any new | ||||
| safety and effectiveness | ||||
| concerns. | ||||
| Minimum | ||||
| braking | ||||
| distance | max safety slope braking: ≤1.6m | |||
| (3°) | 1m | Similar | ||
| Max Speed | ||||
| Forwards | 5.4km/h | 3.75 mph (6 km/h) | Both of the devices are | |
| evaluated according to | ||||
| Max. Speed | ||||
| Backward | 5.4km/h | 2.80 mph (4.5 km/h) | standard | |
| ISO 7176- | ||||
| 6:2018, so the different | ||||
| will not impact the | ||||
| safety and effectiveness | ||||
| Controller | GigaDevice Semiconductor Inc. | PG Drives Technology Ltd., newVSI | Different Although | |
| different controller is | ||||
| used, both the control | ||||
| system, including the | ||||
| joystick controller, the | ||||
| electromagnetic brakes | ||||
| are similar. The joystick | ||||
| controls the directions | ||||
| and speed of movement, | ||||
| and when the joystick is | ||||
| released, the powered | ||||
| wheelchair will slow | ||||
| down to stop and the | ||||
| brakes will | ||||
| automatically re-engage. | ||||
| The controller also | ||||
| provides the battery | ||||
| status displaying and | ||||
| abnormal condition | ||||
| displaying. Both of the | ||||
| control systems are | ||||
| evaluated according to | ||||
| standard ISO 7176- | ||||
| 14:2008 and software | ||||
| validation requirement | ||||
| and there are no new | ||||
| safety and effectiveness | ||||
| concerns due to the | ||||
| difference. | ||||
| Speed control | ||||
| method | Joystick control method | Joystick control method | Same | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Manufacturer | Foshan Dahao Medical | |||
| Technology Co.,Ltd. | JERRY MEDICAL INSTRUMENT | |||
| (SHANGHAI) CO., LTD. | -- | |||
| Main materials | Frame: Aluminiumalloy; | |||
| Wheel, Armrest: PU; | ||||
| Backrest: PU | Frame: Aluminiumalloy; | |||
| Wheel, Armrest: PU; | ||||
| Backrest: oxford cloth | The material for the | |||
| Materials | ||||
| contacting user | Armrest: PU; | |||
| Backrest:PU | ||||
| Seat: PU | ||||
| Joystick controller: TPU(80%), | ||||
| Fire retardant(15%), | ||||
| Fertilize( 5% ). | Armrest: PU; | |||
| Backrest: oxford cloth | ||||
| Seat: oxford cloth | ||||
| newVSi electric wheelchair | ||||
| controller: | ||||
| Joystick knob: Santoprene 101-80; | ||||
| Joystick Gaiter: Silicone 3032 | ||||
| (50%) & 5031 (50%) | ||||
| Enclosure Moulding(s): ABS/PC | ||||
| Wonderloy PC-540 | ||||
| Keypad: Silicone keypad coatings | ||||
| TC-2407 & CH-6330 | main frame is the same. | |||
| Biocompatibility | ||||
| evaluation | ||||
| has | ||||
| been | ||||
| carried out per | ||||
| ISO | ||||
| 10993-1. | ||||
| There are no new safety | ||||
| and | ||||
| effectiveness | ||||
| concerns | ||||
| due to | ||||
| the | ||||
| difference. | ||||
| Biocompatibility | ||||
| of materials | ||||
| contacting user | Comply with ISO 10993-1, FDA | |||
| Cytotoxicity (ISO 10993-5:2009), | ||||
| Sensitization and Irritation | ||||
| Reactivity (ISO 10993-10:2010) | Comply with ISO 10993-1, FDA | |||
| Cytotoxicity (ISO 10993-5:2009), | ||||
| Sensitization and Intracutaneous | ||||
| Reactivity (ISO 10993-10:2010) | Difference | |||
| in | ||||
| the | ||||
| Irritation test,the subject | ||||
| device only made skin | ||||
| contact with the patient, | ||||
| so the skin irritation test | ||||
| was | ||||
| carried | ||||
| out | ||||
| according to ISO10993- | ||||
| 1, and the material in | ||||
| contact with the patient | ||||
| was | ||||
| qualified | ||||
| by | ||||
| test.There are no new | ||||
| safety and effectiveness | ||||
| concerns due to | ||||
| the | ||||
| difference. | ||||
| Label and | ||||
| Labeling | Conforms to FDA Regulatory | |||
| Requirements | Conforms to FDA Regulatory | |||
| Requirements | Same | |||
| Level of | ||||
| Concern of the | ||||
| Software | Moderate | Moderate | Same |
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Table3 Safety Comparison
8. Summary of substantial equivalence discussion
The DH01108 (2) Electric Wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2018, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-19:2008, ISO 7176-21:2009, ISO 7176-22:2014,ISO 7176-25: 2013, IEC 60601-1-2:2014, IEC 62133-2:2017,ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength, Yield Load, and Elongation tests. The
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design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. 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 7176-3:2012. Maximum obstacle climbing, Max Speed and Static stability 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 7176-6: 2018, ISO 7176-10:2008. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010.
The flame retardant test of the seat cushion and armrest of subject device is carried out according to the ISO 7176-16 test. Therefore, the subject device meets the flame retardancy of FDA requirements.
In conclusion, the technological characteristics, features, specifications, 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. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. .
9. Summary of Clinical Test
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the Electric Wheelchair to its predicate device.
10. Conclusion
The differences between DH01108 (2) Electric Wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that DH01108 (2) Electric Wheelchair is substantially equivalent to the legally marketed predicate device.
11. Summary Prepared Date
17 June 2022