(652 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, Electric wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The electric wheelchair 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. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.
The provided text is a 510(k) Premarket Notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than describing acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/medical imaging device. As such, it does not contain the specific information required to answer the prompt comprehensively for an AI-based device.
However, I can extract information related to how this specific device (an electric wheelchair) demonstrates its safety and effectiveness, which serves a similar purpose to "acceptance criteria" and "proving it meets them." The "study" here is non-clinical testing against established engineering standards.
Here's an attempt to answer the prompt based on the provided document, acknowledging that it's for a physical device, not an AI:
Acceptance Criteria and Study for the Electric Wheelchair (Models: JRWD6010 and JRWD6012)
The "acceptance criteria" for this electric wheelchair are primarily defined by adherence to a comprehensive set of ISO standards specific to wheelchairs and related electrical and material safety. The "study" demonstrating the device meets these criteria is a series of non-clinical tests conducted against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document defines acceptance relative to a predicate device and extensive non-clinical testing against ISO standards. The table below summarizes key performance characteristics and their reported values, demonstrating compliance or acceptable differences compared to the predicate device and relevant standards. The "remark" column often serves as the "acceptance" or justification for differences.
| Acceptance Criteria (Defined by ISO Standard Compliance & Predicate Equivalence) | Reported Device Performance (JRWD6010 / JRWD6012) | Rationale/Compliance/Remark (Implicit Acceptance) |
|---|---|---|
| Static Stability (ISO 7176-1:2014) | Forward: 21.8° Rearward: 19° Sideways: 19.2° | Evaluated according to ISO 7176-1:2014. Differences from predicate (which is "Not publicly available" for specific values) are acceptable if standards are met. |
| Dynamic Stability (ISO 7176-2:2017) | Tested | Complies with ISO 7176-2:2017. |
| Brake Effectiveness (ISO 7176-3:2012) | Minimum braking distance: 1m (for both models) | Complies with ISO 7176-3:2012. |
| Energy Consumption/Range (ISO 7176-4:2008) | Cruising Range: 20 km (JRWD6012) | Larger cruising range due to less weight is not a safety concern. Complies with ISO 7176-4:2008. |
| Overall Dimensions, Mass & Maneuvering (ISO 7176-5:2008) | Dimensions: Varied (e.g., 38.1"x24.0"x37.0" for JRWD6010) Weight: Varied (e.g., 58.4 lbs for JRWD6010) Min. Turning radius: 1820mm (JRWD6010) / 833mm (JRWD6012) | Minor differences in dimensions/weight/turning radius do not impact safety and effectiveness. Complies with ISO 7176-5:2008. |
| Max Speed, Acceleration/Deceleration (ISO 7176-6:2018) | Max. Speed Forwards: 3.75 mph (6 km/h) Max. Speed Backward: 2.80 mph (4.5 km/h) (JRWD6010); 1.86 mph (3.0 km/h) (JRWD6012) | Differences in backward speed do not impact safety/effectiveness. Complies with ISO 7176-6:2018. |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | JRWD6010: 1.97" (50mm) JRWD6012: 1.36" (34.5 mm) | Larger height in obstacle climbing (JRWD6010) will not impact safety/effectiveness. Complies with ISO 7176-10:2008. |
| Maximum Safe Operational Incline | JRWD6010: 10 degrees JRWD6012: 8 degrees | Larger safe operational incline (JRWD6010) offers more convenience. Complies with ISO 7176-2:2001 (presumably, as 7176-10 also relates to inclines). |
| Electromagnetic Compatibility (EMC) (ISO 7176-21:2009, IEC 60601-1-2:2015) | Tested | Complies with relevant EMC standards. |
| Biocompatibility of Patient-Contacting Parts (ISO 10993-1, -5, -10) | Materials like joystick knob (Santoprene 101-80), gaiter (Silicone), enclosure (ABS/PC), keypad (Silicone); Armrest (PU), Backrest/Seat (Oxford cloth). Tested for Cytotoxicity, Irritation/Skin Sensitization. | Materials are identical to a cleared predicate (K202482) or assessment carried out according to ISO standards. No new safety concerns. |
| Maximum Loading Capacity | JRWD6010: 220lbs (100kg) JRWD6012: 264lbs (120kg) | Predicate device "Less loading weight means more convenient for the transportation" - this appears to be a favorable difference for the subject device. |
| Flame Retardancy (ISO 7176-16:2012) | Tested for seat cushion/back cushion and armrest. | Assured to be under the same safety level as the predicate. |
| Software Validation | Performed for control systems. | No new safety and effectiveness concerns due to different controllers. |
Note: The document states "Not publicly available" for some predicate device values, and "Same" for others. Where specific numbers for the predicate are missing, the comparison is qualitative or based on standard compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices tested. It refers to extensive non-clinical tests conducted on the proposed device models (JRWD6010 and JRWD6012). For physical device testing against engineering standards, typically a representative number of units (often a small number, e.g., 1-3) are tested to demonstrate compliance of the design.
- Data Provenance: The testing was non-clinical (laboratory/benchtop) and conducted by the manufacturer, Jerry Medical Instrument (Shanghai) Co., Ltd. The document does not explicitly state the country of origin of the test data (beyond the manufacturer's location) or whether it was retrospective or prospective, but it implies a prospective testing approach conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as this document describes non-clinical testing of a physical medical device (electric wheelchair), not an AI/imaging device. The "ground truth" for a physical device is established through calibrated measurement instruments and adherence to internationally recognized engineering standards (ISO). There's no mention of experts in the context of "ground truth" for the performance metrics.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of human readers or subjective assessments requiring adjudication. The tests described are objective, quantitative measurements against predefined criteria in engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. No MRMC study was performed or is relevant for this type of device. The document explicitly states "No clinical study implemented for the electric wheelchair."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical electric wheelchair, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the electric wheelchair's performance is based on:
- Adherence to international engineering standards (e.g., ISO 7176 series for wheelchairs, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility). These standards define test methods and acceptable performance limits.
- Comparison to a legally marketed predicate device, demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this physical device.
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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 13, 2021
Jerry Medical Instrument (Shanghai) Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K192739
Trade/Device Name: Electric Wheelchair (Models: JRWD6010 and JRWD6012) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 31, 2021 Received: June 16, 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/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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 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/cdrl-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 Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192739
Device Name
Electric Wheelchair (Models: JRWD6010 and JRWD6012)
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
(K192739)
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: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Address: Building 12, No. 615 Fengdeng Rd, Malu Town, Jiading District, Shanghai 201801, China Tel: 86-13817397985 Fax: 86-21-59517526 Contact: Jianguo Chen Date of Preparation: May 31,2021
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: Electric Wheelchair Powered Wheelchair Common name: Classification name: Powered Wheelchair Model(s): JRWD6010, JRWD6012
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)
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510(k) number: K170787
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, Electric wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The electric wheelchair 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.
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:
-
The tube of this product is A6061-T4 aluminum, and the frame tube mostly is D22.22.0t aluminum tube. (The main frame of JRWD6012 is 80252.0t aluminum tube, and the main frame of JRWD6010 is 4022.2*2.0t flat oval 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 electric wheelchair has two models: JRWD6010, JRWD6012.
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Model JRWD6010: 8 inch front wheel and 10 inch rear tire. Modle JRWD6012: 8 inch front wheel and 12inch rear tire.
The motor of electric wheelchair is DC24V 180W; the battery is 24V 20AH, Li-ion battery; the charger is 24V/6A. Max. loading can not be over than 100Kgs. 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 10 degrees. Obstacle climbing ability: 1.97" Do not use outdoors
7.0 Summarv 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 maneuvering space ISO 7176-6: 2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs ISO 7176-7 : 1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8 : 2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue 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,
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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
IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests 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 materials of the Joystick knob, Joystick Gaiter, Enclosure Mouldings and Keypad of new/Si electric wheelchair controller & Joystick of the Electric Wheelchair, model JRWD6010, JRWD6012, manufactured by JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. are identical to the materials of newVSi electric wheelchair controller & Joystick of the Y207 Electric Wheelchair, Model Y207, JIANGSU INTCO MEDICAL PRODUCTS CO., LTD, K202482, clearance date 03/18/2021, in formulation, processing, and geometry, and no other chemicals have been added. The patient-contacting materials of the new/Si electric wheelchair controller & Joystick of the Electric Wheelchair, JRWD6010, JRWD6012, have the same nature of tissue contact and contact duration (e.g., surface device category, intact skin contact, less than 24-hour duration) as the Y207 Electric Wheelchair, ModelY207.
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 Summarv of Clinical Testing
No clinical study implemented for the electric wheelchair.
9.0 Technological Characteristic Comparison Table
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| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Electric Wheelchair | Powered Wheelchair | - |
| DYW30A(D09) | |||
| 510(k) No. | K192739 | K170787 | - |
| Models | JRWD6010 JRWD6012 | DYW30A(D09) | - |
| Intended 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 |
| PatientPopulation | 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 ofwheels | 4 | 4 | Same |
| Main framematerial | Aluminium alloy | Aluminium alloy | Same |
| Motor | DC24V* 180W*2pcs | 24 VDC *250W * 2 pcs | |
| Battery | DC 24V 20Ah Lithium-ion | Lithium-ion, ITP2406 | Minor differences in the |
| 1 pcs | 6 Ah x 24 VDC x 2 pcs | dimensions will not | |
| High Power TechnologyInc. | High Power TechnologyInc. | impact the safety and | |
| effectiveness of the | |||
| Battery charger | HP0180WL2 | HP0060W(L2) | substantial equivalence. |
| Input: 100-240 VAC | Input: 100-240 VAC | ||
| Output: DC 24V, 6 Amp | Output: DC 24V, 2 Amp |
Table1-General Comparison
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Table2 Performance Comparison
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| JRWD6010 | JRWD6012 | |||
| Dimensions | 38.1"x24.0"x37.0" | 39.3"x23.6"x37.0" | 37.4" x 22.6" x 36.2" | Minor differences in thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| Weight, w/Battery | 58.4 lbs. /26.5kg | 58.2 lbs. /26.4kg | 51.8" lbs. / 23.5 kg | The difference willnot raise any new safetyand effectivenessconcerns. |
| 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 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 andtwoanti-tippers in the rear. | Same |
| Foldingmechanism | A foldable seat frames(The backrest could be folded toseat) | A foldable seat frames(The backrest could be folded toseat) | A foldable seat frames(The backrest could befolded to seat) | Same |
| Frontwheel(inch) | 8(PU solid tire) | 8 | 7(PU solid tire) | Larger sizes of frontwheels bring steadierpivoting function thanpredicate device. |
| Rear tire (inch) | 10(PU solid tire) | 12(Pneumatic tire) | 12.5(PU solid tire) | Smaller sizes of rear wheels,The difference will not raiseany new safety andeffectiveness concerns. |
| CruisingRange(km) | 20 | 18 | This difference is due tothe less weight for thesubject device.There is a larger cruisingrange for the subject device. | |
| Obstacle | 50 | The larger height in the | ||
| climbing(mm) | obstacle climbing will notimpact the safety andeffectiveness of the subjectdevice. | |||
| Max. Speed(km/h) | 6 | 6 | Same | |
| Static stabilityforward | 21.8° | Both of the devices areevaluated according tostandard ISO 7176-1:2014, | ||
| Static stabilityrearward | 19° | Not publicly available | so the different static stability | |
| Static stabilitysideways | 19.2° | will not impact the safetyand effectiveness | ||
| Max. loading(kg) | 220lbs(100kg) | 264lbs (120kg) | Less loading weight meansmore convenient for thetransportation | |
| Maximum safeoperationalincline | 10 degrees | 8 degrees | Larger safe operationalincline of subject bring moreconvenient for the useenvironment | |
| Min. Turningradium | 1820mm | 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 | 1m | 1 m | Same | |
| Max SpeedForwards | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same | |
| Max. SpeedBackward | 2.80 mph (4.5 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., newVSI | 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: oxford cloth | Frame: Aluminium alloy;Wheel, Armrest: PU;Backrest: PVC Vinyl | Biocompatibilityevaluation hasbeen carried outper ISO 10993-1. | |
| Materialscontactinguser | Armrest: PU;Backrest: oxford clothSeat: oxford clothnewVSi electric wheelchair controller:Joystick knob: Santoprene101-80;Joystick Gaiter: Silicone 3032 (50%) &5031 (50%)Enclosure Moulding(s): ABS/PCWonderloy PC-540Keypad: Silicone keypadcoatings TC-2407& CH-6330 | Armrest: PU;Seat: PVC VinylBackrest: PVC VinylSafety belt: PVC VinylJoystick: PVC Vinyl | There are no newsafety andeffectivenessconcerns due to thedifference. | |
| Biocompatibilit | Comply with ISO 10993-1, FDA | Comply with ISO 10993-1, FDA | Same |
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| y of materials contacting user | Guidance, Tests included | Guidance, Tests included | |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Cytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | ||
| Label andLabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | Same |
| Level ofConcern of theSoftware | Moderate | Moderate | Same |
Summary of substantial equivalence discussion:
The Electric Wheelchair model JRWD6010 and JRWD6012 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. ાડભ 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.
Conclusion 10.0
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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 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).