(162 days)
No
The description details a standard electrically powered wheelchair with a joystick and controller, without mentioning any AI or ML components or functionalities.
Yes
The device is an electrically powered wheelchair, explicitly stated to provide mobility to disabled or elderly individuals limited to a seated position, which directly addresses a medical need and provides a therapeutic benefit.
No
The device is described as an Electrically Powered Wheelchair intended to provide mobility, not to diagnose medical conditions.
No
The device is an electrically powered wheelchair, which is a physical hardware device with mechanical and electrical components, not solely software.
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 mechanical and electrical device for transportation. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on mechanical and electrical standards (ISO standards related to wheelchairs) and biocompatibility. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in the body.
- Diagnosis, monitoring, or screening of diseases or conditions.
Therefore, this device, an Electrically Powered Wheelchair, falls under the category of a medical device for mobility assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The proposed device, Electrically Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The Electrically Powered Wheelchair consists of two foldable armrests, a backrest, a cushion, a foldable frame, two rear driving wheels with hub seat motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.
Folding design: This foldable electric wheelchair has main frame, rear frame, backrest frame, seat frame, front wheel frame and battery frame. Release the locking device of the backrest frame and the rear frame, push the backrest frame downward, drive the seat frame to rotate toward the backrest frame with the rotating mechanism, the two armrest frames rotate towards the direction of the seat frame. At the same time two front wheel frames move to the direction of the seat frame. When the back cushion is in contact with the seat cushion, the folding is completed.
Joystick: This controls the speed and direction of the wheelchair. Push the joystick in the direction you wish to go. The further you push it, the faster the speed. Releasing the joystick stops the wheelchair and automatically applies the brakes.
Controller: The controller includes a power switch, a speed adjustment button, a horn button and a direction joystick. The operation interface controller receives the operation signal and transmits it to the main board of the controller body, and sends a control signal to the electric wheelchair to adjust and operate the electric wheelchair.
Wheel and frame connection method: First, the left and right frames are connected to the motor respectively, and then the motor shaft is connected to the wheel. The motor rotates to drive the wheels to rotate to drive the wheelchair.
Frame design: 1. The frame tube of this product is mostly is aluminum tube.
- 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 subject device has 6 inch front wheel and 10 inch rear tire.
The motor of electric wheelchair is DC24V 120W; the battery is 25.2V 10.4AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
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
Indoor 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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
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 manoeuvring 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 fatique 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 7176-13 : 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 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
IEC 62133:2012 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
Biocompatibility of patient-contacting parts:
Statement for Biocompatibility Certification
The VR2 Controller/Joystick of the Electrically Powered Wheelchair, model HP458E,are identical to the VR2 Controller/Joystick of the KARMA Power Wheelchair, model KP-10.3S, manufactured by KARMA Medical Products Co., Ltd., under K202506, cleared on January 16, 2021 in formulation, processing, sterilization, and geometry, and no other chemicals have been added.
The VR2 Controller/Joystick of the HP458E Electrically Powered Wheelchair has the same nature of tissue contact and contact duration (Surface device category, intact skin contact, less than 24-hour duration) as Karma Powered Wheelchair, KP-10.3S.
Other patient-contacting material are carried out biocompatibility assessment in accordance with IS0 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
No clinical study implemented for the electric wheelchair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 9, 2022
Kunshan Hi-Fortune Health Products Co., Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212503
Trade/Device Name: Electrically Powered Wheelchair (Model: HP458E) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI
Dear Boyle Wang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 18, 2022. Specifically, FDA is updating this SE Letter to update the contact name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Heather Dean, OHT5: Office of Neurological and Physical Medicine Devices, 240-402-9874, Heather.Dean@fda.hhs.gov.
Sincerelv.
Heather L. Dean -S
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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
January 18, 2022
Zhejiang Qianxi Vehicle Co., Ltd. % Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801. No.161. East Luiiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212503
Trade/Device Name: Electrically Powered Wheelchair (Model: HP458E) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 14, 2021 Received: October 20, 2021
Dear Boyle 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 (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/ofdocs/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
2
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 (OS) 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 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-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,
Heather L. Dean -S
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
510(k) Number (if known) K212503
Device Name
Electrically Powered Wheelchair (Model: HP458E)
Indications for Use (Describe)
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.
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
(K212503)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Kunshan Hi-Fortune Health Products Co.,Ltd. Address: No. 625,Juxiang Road,Zhangpu Town,Kunshan City,Jiangsu Province,China Tel: 86-512-55195100 Contact: Mr.Jianjiang Fan Date of Preparation: Dec.20,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Electrically Powered Wheelchair Powered Wheelchair Common name: Classification name: Powered Wheelchair Model(s): HP458E
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd. Device: Powered Wheelchair DYW30A(D09) 510(k) number: K170787
5
5.0 Indication for Use Statement
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.
6.0 Device description
The proposed device, Electrically Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The Electrically Powered Wheelchair consists of two foldable armrests, a backrest, a cushion, a foldable frame, two rear driving wheels with hub seat motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.
Folding design: This foldable electric wheelchair has main frame, rear frame, backrest frame, seat frame, front wheel frame and battery frame. Release the locking device of the backrest frame and the rear frame, push the backrest frame downward, drive the seat frame to rotate toward the backrest frame with the rotating mechanism, the two armrest frames rotate towards the direction of the seat frame. At the same time two front wheel frames move to the direction of the seat frame. When the back cushion is in contact with the seat cushion, the folding is completed.
Joystick: This controls the speed and direction of the wheelchair. Push the joystick in the direction you wish to go. The further you push it, the faster the speed. Releasing the joystick stops the wheelchair and automatically applies the brakes.
Controller: The controller includes a power switch, a speed adjustment button, a horn button and a direction joystick. The operation interface controller receives the operation signal and transmits it to the main board of the controller body, and sends a control signal to the electric wheelchair to adjust and operate the electric wheelchair.
Wheel and frame connection method: First, the left and right frames are connected to the motor respectively, and then the motor shaft is connected to the wheel. The motor rotates to drive the wheels to rotate to drive the wheelchair.
Frame design: 1. The frame tube of this product is mostly is aluminum tube.
- 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 subject device has 6 inch front wheel and 10 inch rear tire.
The motor of electric wheelchair is DC24V 120W; the battery is 25.2V 10.4AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
The following surfaces are re commended NOT to operate on:
Sand surface
Wet or icy surface
Road maintenance hole metal cover
6
Do not use on stairs Do not use escalators. Use the elevator. Too steep incline over 6 degrees. Obstacle climbing ability: 1.97" Do not use outdoors
7.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
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 manoeuvring 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 fatique 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 7176-13 : 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 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid
7
electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
Biocompatibility of patient-contacting parts
Statement for Biocompatibility Certification
The VR2 Controller/Joystick of the Electrically Powered Wheelchair, model HP458E,are identical to the VR2 Controller/Joystick of the KARMA Power Wheelchair, model KP-10.3S, manufactured by KARMA Medical Products Co., Ltd., under K202506, cleared on January 16, 2021 in formulation, processing, sterilization, and geometry, and no other chemicals have been added.
The VR2 Controller/Joystick of the HP458E Electrically Powered Wheelchair has the same nature of tissue contact and contact duration (Surface device category, intact skin contact, less than 24-hour duration) as Karma Powered Wheelchair, KP-10.3S.
Other patient-contacting material are carried out biocompatibility assessment in accordance with IS0 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
8.0 Summary of Clinical Testing
No clinical study implemented for the electric wheelchair.
9.0 Technological Characteristic Comparison Table
8
| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Electrically Powered | ||
| Wheelchair | Powered Wheelchair | ||
| DYW30A(D09) | - | ||
| 510(k) No. | K212503 | K170787 | - |
| Models | HP458E | DYW30A(D09) | - |
| Intended Use/ | |||
| Indications for | |||
| use | 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. | 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 | ||
| 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 | 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. | Two foldable armrests, a seat | ||
| belt, a backrest, a seat cushion, | |||
| a foldable frame, two rear driving | |||
| wheels with hub motor/ | |||
| electromagnetic brake | |||
| assemblies, two pivoting | |||
| casters, two Li-ion batteries, an | |||
| off-board battery charger, a | |||
| control panel, and an electric | |||
| motor controller. | Similar | ||
| 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 | DC24V* 120W*2pcs | 24 VDC *250W * 2 pcs | Minor differences in the |
| Battery | DC 25.2V 10.4Ah | ||
| Lithium ion 2 pcs | Lithium-ion, ITP2406 | ||
| 6 Ah x 24 VDC x 2 pcs | dimensions will not | ||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| High Power Technology | |||
| Inc. | |||
| HP0060W(L2) | |||
| Input: 100-240 VAC | |||
| Output: DC 24V, 2 Amp | High Power Technology | ||
| Inc. | |||
| HP0060W(L2) | |||
| Input: 100-240 VAC | |||
| Output: DC 24V, 2 Amp | Same | ||
| Battery charger |
Table1-General Comparison
9
Table2 Performance Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Dimensions | 39.0"x24.4"x34.6" | 37.4" x 22.6" x 36.2" | Minor differences in the |
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Folded | |||
| Dimensions | 28.3"x13.4"x28.0" | Not publicly available | The folded dimensions are |
| not publicly available, but no | |||
| impact on safety and | |||
| effectiveness. | |||
| Weight, w/ | |||
| Battery | 41.9 lbs. /19.0kg | 51.8" lbs. / 23.5 kg | Less weight will lead to |
| more convenience when | |||
| transported and there is | |||
| more cruising range than | |||
| predicate 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 two | |||
| 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) | 7 | ||
| (PU solid tire) | Smaller sizes of font wheels, | ||
| The difference will not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Rear tire (inch) | 10 | ||
| (PU solid tire) | 12.5 | ||
| (PU solid tire) | Smaller sizes of rear wheels, | ||
| The difference will not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Cruising | 15 | 18 | There is a smaller cruising |
| Range(km) | range for the subject device. | ||
| Obstacle | |||
| climbing(mm) | 50 | 34.5 | The larger height in the |
| obstacle climbing will not | |||
| impact the safety and | |||
| effectiveness of the subject | |||
| device. | |||
| Max. Speed | |||
| (km/h) | 6 | 6 | Same |
| Static stability | |||
| forward | 16.5° | Not publicly available | 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 | 16.5° | ||
| Static stability | |||
| sideways | 17° | ||
| Max. loading | |||
| (kg) | 264lbs (120kg) | 264lbs (120kg) | Same |
| Maximum safe | |||
| operational | |||
| incline | 6 degrees | 8 degrees | Small safe operational incline |
| of subject device. | |||
| Min. Turning | |||
| radium | 1000mm | 833 mm | The difference in the turning |
| radius will bring more | |||
| convenience when it | |||
| turns. The difference will not | |||
| raise any new safety and | |||
| effectiveness concerns. | |||
| Maximum | |||
| obstacle | |||
| climbing | 1.97"(50mm) | 1.36" (34.5 mm) | The larger height in the |
| obstacle climbing will | |||
| not impact the safety | |||
| and effectiveness of the | |||
| subject device. | |||
| Minimum | |||
| braking | |||
| distance | 1 m | 1m | Same |
| Max Speed | |||
| Forwards | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same |
| Max. Speed | |||
| Backward | 1.79 mph (2.88 km/h) | 1.86 mph (3.0 km/h) | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety | |||
| and effectiveness | |||
| Controller | PG Drives Technology Ltd., VR2 | Changzhou Billon | |
| Electronic Appliance | |||
| Co Ltd WS-1 | Different | ||
| Although different controller | |||
| is used, both the control | |||
| system, including the joystick controller, the electromagnetic brakes and the user interface 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 |
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Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Main materials | Frame: Aluminium alloy; | ||
| Wheel, Armrest: PU; | |||
| Backrest/ Cushion/Seat: Terylene | Frame: Aluminium alloy; | ||
| Wheel, Armrest: PU; | |||
| Backrest: PVC Vinyl | Biocompatibility | ||
| evaluation has | |||
| been carried out | |||
| per ISO 10993-1. | |||
| There are no new | |||
| safety and | |||
| effectiveness | |||
| concerns due to the | |||
| difference. | |||
| Materials | |||
| contacting | |||
| user | Armrest: PU; | ||
| Backrest/Cushion/Seat:Terylene | |||
| VR2 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 | Armrest: PU; | ||
| Seat: PVC Vinyl | |||
| Backrest: PVC Vinyl | |||
| Safety belt: PVC Vinyl | |||
| Joystick: PVC Vinyl | |||
| Biocompatibilit | |||
| y of materials | |||
| contacting | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included | |||
| Cytotoxicity (ISO 10993-5:2009), | Comply with ISO 10993-1, FDA | ||
| Guidance, Tests included | |||
| Cytotoxicity (ISO 10993-5:2009), | Same |
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| user | Sensitization and Intracutaneous
Reactivity (ISO 10993-10:2010) | Sensitization and Intracutaneous
Reactivity (ISO 10993-10:2010) | |
|-----------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|----------|
| Label and
Labeling | Conforms to FDA Regulatory
Requirements | Conforms to FDA Regulatory
Requirements | Same |
| | Level of
Concern of the
Software | Moderate | Moderate |
Summary of substantial equivalence discussion:
The Electrically Powered Wheelchair model HP458E complied with the requirements of ISO 7176-1:2014. ISO 7176-2:2017. ISO 7176-3:2012. ISO 7176-4:2008. ISO 7176-5:2008, ISO 7176-6:2001, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, IEC 60601-1-2: 2014, IEC 62133:2012, 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 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 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 7176-2:2001, 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/back cushion and armrest of both subject device and predicate device is carried out according to the ISO 7176-16 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. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed
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predicated device in K170787 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.