(162 days)
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 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
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
This document is a 510(k) Premarket Notification for an Electrically Powered Wheelchair (Model: HP458E). It focuses on demonstrating substantial equivalence to a predicate device (Powered Wheelchair DYW30A(D09), K170787) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/ML-driven medical device.
Therefore, the requested information regarding acceptance criteria, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document, as it pertains to a different type of medical device submission (electrically powered wheelchair) and does not involve AI/ML.
The document primarily relies on non-clinical testing against established ISO standards for wheelchairs and a comparison of technological characteristics to assert substantial equivalence.
However, I can extract information related to the device's technical specifications and the standards it meets, which serve as its "acceptance criteria" in the context of mechanical and electrical performance.
Here's an interpretation based on the provided document, assuming "acceptance criteria" generally refers to the performance specifications and safety standards the device is required to meet:
1. Table of Acceptance Criteria and Reported Device Performance
For an electrically powered wheelchair, "acceptance criteria" are defined by compliance with relevant international standards and performance specifications that demonstrate safety and effectiveness. The reported device performance is demonstrated through testing against these standards and by comparing its technical specifications to a predicate device.
| Acceptance Criteria (Defined by Standards/Specifications) | Reported Device Performance (HP458E) | Remark |
|---|---|---|
| Intended Use | Motor-driven, indoor transportation vehicle for mobility of disabled or elderly persons limited to a seated position. | Same as predicate, indicates target performance. |
| Regulation Number | 21 CFR 890.3860 | Device falls under this regulation. |
| Regulatory Class | Class II | Device is Class II. |
| Product Code | ITI | Device uses product code ITI. |
| Static Stability (ISO 7176-1:2014) | Forward: 16.5°, Rearward: 16.5°, Sideways: 17° | Meets standard; specific values provided. Predicate's values not publicly available but also evaluated per this standard. |
| Dynamic Stability (ISO 7176-2:2017) | Complies with standard (implied by overall compliance statement) | Met. |
| Effectiveness of Brakes (ISO 7176-3:2012) | Minimum braking distance: 1 m | Meets standard; same as predicate. |
| Energy Consumption (ISO 7176-4:2008) | Cruising Range: 15 km | Met. Predicate had 18km, subject device has smaller range but deemed acceptable. |
| Overall Dimensions, Mass & Maneuvering Space (ISO 7176-5:2008) | Dimensions: 39.0"x24.4"x34.6"; Weight w/Battery: 41.9 lbs (19.0kg); Min. Turning Radius: 1000mm | Met. Dimensions differ subtly from predicate but no safety/effectiveness impact. Lighter weight is a benefit. Turning radius difference does not raise concerns. |
| Maximum Speed, Acceleration & Deceleration (ISO 7176-6:2018) | Max. Speed Forwards: 3.75 mph (6 km/h); Max. Speed Backward: 1.79 mph (2.88 km/h) | Meets standard; Max Forward Speed same as predicate. Max Backward Speed differs slightly but within acceptable limits after evaluation. |
| Obstacle-climbing Ability (ISO 7176-10:2008) | Obstacle Climbing: 50mm (1.97") | Meets standard; reportedly better than predicate (34.5mm). Deemed not to impact safety/effectiveness. |
| Maximum Loading | 264 lbs (120kg) | Same as predicate. |
| Maximum Safe Operational Incline | 6 degrees | Meets requirements. Predicate was 8 degrees, but 6 degrees for subject device is still safe. |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16:2012) | Complies with standard (implied by overall compliance statement) | Met. |
| Electromagnetic Compatibility (ISO 7176-21:2009) | Complies with standard (implied by overall compliance statement) | Met. |
| Biocompatibility (ISO 10993-1:2018, -5:2009, -10:2010) | All patient-contacting parts assessed; "identical" joystick components to a cleared device (K202506), others tested for cytotoxicity, irritation, skin sensitization. | Met. Deemed safe due to compliance with standards and comparison to previously cleared components. |
| Software Level of Concern | Moderate | Evaluated, no new concerns. |
2. Sample size used for the test set and the data provenance
- Test Set: Not applicable in the biological/imaging data sense, as this is a mechanical/electrical device. The "test set" here refers to the actual physical device model (HP458E) that underwent non-clinical performance and safety testing.
- Data Provenance: The tests were conducted according to international standards (ISO, IEC). The document does not specify the country of origin for the testing data or whether it was retrospective or prospective, beyond stating "non clinical tests were conducted to verify that the proposed device met all design specifications."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device relying on expert interpretation for ground truth. Ground truth for a wheelchair's performance is established by objective measurements and standardized testing procedures (e.g., measuring speed, stability angles, braking distance according to ISO standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance and safety is defined by international consensus standards (ISO, IEC) that specify test methods and acceptable performance limits for wheelchairs. This includes objective measurements of physical properties (e.g., dimensions, weight), dynamic performance (speed, braking, climbing), stability, and material properties (biocompatibility, flame retardancy).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image 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
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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
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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
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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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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
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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
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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
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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
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| 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 PoweredWheelchair | Powered WheelchairDYW30A(D09) | - |
| 510(k) No. | K212503 | K170787 | - |
| Models | HP458E | DYW30A(D09) | - |
| Intended Use/Indications foruse | The device is amotor-driven, and indoortransportation vehicle withthe intended use to providemobility to a disabled or anelderly person limited to aseated position. | The device is a motor-driven,and indoor transportation vehiclewith the intended use to providemobility to a disabled or anelderly person limited to aseated position. | Same |
| Use environment | Indoor use | Indoor use | Same |
| PatientPopulation | The electric wheelchair isintended to provide mobilityto a person with a disabilityor an older adult limited to asitting position | The electric wheelchair isintended to provide mobility to aperson with a disability or anolder adult limited to a sittingposition | Same |
| Product structure | Consists of two foldablearmrests, a backrest, a seatcushion, a foldable frame,two rear driving wheels withhub motor/electromagnetic brakeassemblies, two pivotingcasters, a Li-ion batteries,an off-board batterycharger, a control panel,and an electric motorcontroller. | Two foldable armrests, a seatbelt, a backrest, a seat cushion,a foldable frame, two rear drivingwheels with hub motor/electromagnetic brakeassemblies, two pivotingcasters, two Li-ion batteries, anoff-board battery charger, acontrol panel, and an electricmotor controller. | Similar |
| Driving system | Direct drive on the rearwheels | Direct drive on the rear wheels | Same |
| Number ofwheels | 4 | 4 | Same |
| Main framematerial | Aluminium alloy | Aluminium alloy | Same |
| Motor | DC24V* 120W*2pcs | 24 VDC *250W * 2 pcs | Minor differences in the |
| Battery | DC 25.2V 10.4AhLithium ion 2 pcs | Lithium-ion, ITP24066 Ah x 24 VDC x 2 pcs | dimensions will notimpact the safety and |
| effectiveness of thesubstantial equivalence. | |||
| High Power TechnologyInc.HP0060W(L2)Input: 100-240 VACOutput: DC 24V, 2 Amp | High Power TechnologyInc.HP0060W(L2)Input: 100-240 VACOutput: DC 24V, 2 Amp | Same | |
| Battery charger |
Table1-General Comparison
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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 thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| FoldedDimensions | 28.3"x13.4"x28.0" | Not publicly available | The folded dimensions arenot publicly available, but noimpact on safety andeffectiveness. |
| Weight, w/Battery | 41.9 lbs. /19.0kg | 51.8" lbs. / 23.5 kg | Less weight will lead tomore convenience whentransported and there ismore cruising range thanpredicate device. |
| Frame design | Foldable/The device consists of a foldableand non-rigid type of powerwheelchair base with rear drive and2 casters in the front and twoanti-tippers in the rear. | Foldable/The device consists of afoldable and non-rigidtype of power wheelchairbase with rear drive and 2casters in the front andtwo anti-tippers in the rear. | Same |
| Foldingmechanism | A foldable seat frames(The backrest could be foldedto seat) | A foldable seat frames(The backrest couldbe folded to seat) | Same |
| Frontwheel(inch) | 6(PU solid tire) | 7(PU solid tire) | Smaller sizes of font wheels,The difference will not raiseany new safety andeffectiveness concerns. |
| Rear tire (inch) | 10(PU solid tire) | 12.5(PU solid tire) | Smaller sizes of rear wheels,The difference will not raiseany new safety andeffectiveness concerns. |
| Cruising | 15 | 18 | There is a smaller cruising |
| Range(km) | range for the subject device. | ||
| Obstacleclimbing(mm) | 50 | 34.5 | The larger height in theobstacle climbing will notimpact the safety andeffectiveness of the subjectdevice. |
| Max. Speed(km/h) | 6 | 6 | Same |
| Static stabilityforward | 16.5° | Not publicly available | Both of the devices areevaluated according tostandard ISO 7176-1:2014,so the different static stabilitywill not impact the safetyand effectiveness |
| Static stabilityrearward | 16.5° | ||
| Static stabilitysideways | 17° | ||
| Max. loading(kg) | 264lbs (120kg) | 264lbs (120kg) | Same |
| Maximum safeoperationalincline | 6 degrees | 8 degrees | Small safe operational inclineof subject device. |
| Min. Turningradium | 1000mm | 833 mm | The difference in the turningradius will bring moreconvenience when itturns. The difference will notraise any new safety andeffectiveness concerns. |
| Maximumobstacleclimbing | 1.97"(50mm) | 1.36" (34.5 mm) | The larger height in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device. |
| Minimumbrakingdistance | 1 m | 1m | Same |
| Max SpeedForwards | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same |
| Max. SpeedBackward | 1.79 mph (2.88 km/h) | 1.86 mph (3.0 km/h) | The devices are evaluatedaccording to standard ISO7176-6:2018, so the differentwill not impact the safetyand effectiveness |
| Controller | PG Drives Technology Ltd., VR2 | Changzhou BillonElectronic ApplianceCo Ltd WS-1 | DifferentAlthough different controlleris 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 controlmethod | 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 | Biocompatibilityevaluation hasbeen carried outper ISO 10993-1.There are no newsafety andeffectivenessconcerns due to thedifference. |
| Materialscontactinguser | Armrest: PU;Backrest/Cushion/Seat:TeryleneVR2 electric wheelchair controller:Joystick knob: Santoprene101-80;Joystick Gaiter: Silicone 3032 (50%) &5031 (50%)Enclosure Moulding(s): ABS/PCWonderloy PC-540Keypad: Silicone keypad coatingsTC-2407 & CH-6330 | Armrest: PU;Seat: PVC VinylBackrest: PVC VinylSafety belt: PVC VinylJoystick: PVC Vinyl | |
| Biocompatibility of materialscontacting | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009), | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009), | Same |
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| user | Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | |
|---|---|---|---|
| Label andLabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | Same |
| Level ofConcern of theSoftware | 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.
§ 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).