(58 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This Electric Wheelchair, models: HBLD3-B, HBLD3-E, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 20 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V. 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electronic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
The provided text describes a 510(k) premarket notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing against various ISO standards. There is no information within the document about the acceptance criteria or a study that proves a device meets specific clinical performance acceptance criteria related to AI or diagnostic accuracy. The document is for a physical medical device (Electric Wheelchair) and not an AI-enabled diagnostic tool.
Therefore, for your request, I can only extract information related to the non-clinical testing performed to show substantial equivalence.
Here's a breakdown of the available information based on your request, with the understanding that it pertains to non-clinical performance and not the type of clinical or AI-related study you might be expecting:
1. A table of acceptance criteria and the reported device performance
The document states that "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 acceptance criteria are implicit in meeting the requirements of the standards listed, and the reported performance is simply that the device "meets its design specification" or "meet the requirements." Specific numerical performance data or acceptance criteria are not provided in detail beyond the summary statements.
| Acceptance Criteria (based on ISO Standards Compliance) | Reported Device Performance (Summary Statement) |
|---|---|
| Compliance with ISO 10993-5: 2009 (Cytotoxicity) | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. |
| Compliance with ISO 10993-10:2021 (Irritation And Skin Sensitization) | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. |
| Compliance with ISO 10993-23: 2021 (Irritation) | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. |
| Compliance with ISO 7176-1: 2014 (Static stability) | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. |
| Compliance with ISO 7176-2:2017 (Dynamic stability) | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. |
| Compliance with ISO 7176-3: 2012 (Effectiveness of brakes) | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. |
| Compliance with ISO 7176-4 (Theoretical distance range) | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. |
| Compliance with ISO 7176-5 (Overall dimensions, mass and manoeuvring space) | The dimensions, mass has been determined after the testing according to the ISO 7176-5 |
| Compliance with ISO 7176-6: 2018 (Maximum speed, acceleration and deceleration) | The dimensions, mass has been determined after the testing according to the ISO 7176-6 |
| Compliance with ISO 7176-7 (Measurement of seating and wheel dimensions) | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 |
| Compliance with ISO 7176-8:2014 (Static, impact and fatigue strengths) | All test results meet the requirements in Clause 4 of ISO 7176-8 |
| Compliance with ISO 7176-9:2009 (Climatic tests) | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 |
| Compliance with ISO 7176-10:2008 (Obstacle-climbing ability) | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10 |
| Compliance with ISO 7176-11:2012 (Test dummies) | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 |
| Compliance with ISO 7176-13 (Coefficient of friction of test surfaces) | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved |
| Compliance with ISO 7176-14:2008 (Power and control systems) | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 |
| Compliance with ISO 7176-15:1996 (Information disclosure, documentation and labeling) | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 |
| Compliance with ISO 16840-10:2021 (Resistance to ignition of postural support devices) | The performance of resistance to ignition meet the requirements of ISO 16840-10 |
| Compliance with ISO 7176-21:2009 (Electromagnetic compatibility) | The EMC performance results meet the requirements of ISO 7176-21 |
| Compliance with ISO 7176-25:2022 (Lead-acid batteries and chargers) | (Not explicitly stated in table, but listed as standard complied with in G. Non-Clinical Test Conclusion) |
| Compliance with FDA Regulatory requirements for Label and labeling | Conforms to FDA Regulatory |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is for a medical device (Electric Wheelchair) and describes non-clinical performance testing. It does not refer to a "test set" in the context of data for an AI algorithm. The testing was conducted on the physical device itself. The provenance of the testing data is that it was performed by/for Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. (China) to demonstrate compliance with international standards. Details on specific test sample sizes (e.g., number of wheelchairs tested) are not provided. The testing is inherently prospective for the device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document is about non-clinical testing of a physical device against engineering standards, not an AI algorithm requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as above.
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
This section is not applicable as the document is about an Electric Wheelchair and does not involve AI or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the document is about an Electric Wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable. The "ground truth" for the non-clinical tests is defined by the technical specifications and requirements outlined in the ISO standards, which are objective engineering measurements and performance criteria.
8. The sample size for the training set
This section is not applicable as the document is about an Electric Wheelchair and does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as above.
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Image /page/0/Picture/0 description: The image contains 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.
May 31, 2024
Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China
Re: K240913
Trade/Device Name: Electric Wheelchair (HBLD3-B): Electric Wheelchair (HBLD3-E) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 3, 2024 Received: April 3, 2024
Dear Jarvis Wu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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 Rehabilitation Devices
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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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
Indications for Use (Describe)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China 510(K) Summary K240913
Document Prepared Date: 2024/5/20
Applicant: A.
Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd Address: 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China Contact Person: Joy Ding Tel: +86- 13472703037
Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Electric Wheelchair Common Name: Powered wheelchair Models: HBLD3-B, HBLD3-E
Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China
C. Predicate device:
510Knumber: K220747
Device Name: Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
D. Reference device:
510Knumber: K212092
Device Name: Power Wheelchair Model: DC01
Anhui JBH Medical Apparatus Co., Ltd
E. Indications for use of the device:
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
F. Device Description:
This Electric Wheelchair, models: HBLD3-B, HBLD3-E, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger.
The device is powered by Li-ion Battery pack with 20 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V. 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electronic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
G. Non-Clinical Test Conclusion
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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro > Cytotoxicity
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
-
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 7176-1: 2014. Wheelchairs Part 1: Determination of static stability >
- ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs >
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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd
1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China
-
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric > wheelchairs and wheelchairs for determination of theoretical distance range
-
ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- ISO 7176-6: 2018, Wheelchairs Part 6: Determination of maximum speed, acceleration A and deceleration of Powered Wheelchairs
-
ISO 7176-7, 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 Powered 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, First edition 1989-08-01, 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 wheelchairs - Requirements and test methods
-
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support > devicesRequirements and test method.
-
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
- ISO 7176-25:2022 Wheelchairs Part 25: Lead-acid batteries and chargers for powered wheelchairs > Requirements and test methods
H. Clinical Test Conclusion
No clinical study is included in this submission.
Comparison with predicate Device L
| Elements ofComparison | Subject Device(K240913) | Predicate Device(K220747) | ReferenceDevice(K212092) | Remark |
|---|---|---|---|---|
| Manufacturer | Shanghai HubangIntelligentRehabilitationEquipment Co., Ltd | Zhejiang InnuovoRehabilitationDevices Co.,Ltd | Anhui JBH MedicalApparatus Co., Ltd | - |
| Common or Usualname | Power Wheelchair | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | HBLD3-B, HBLD3-E | N5515B | DC01 | -- |
| Indications for use | It is a motor driven,indoor and outdoortransportation vehiclewith the intended useto provide mobility toa disabled or elderlyperson limited to aseated position. | It is a motor driven,indoor and outdoortransportation vehiclewith the intended useto provide mobility toa disabled or elderlyperson limited to aseated position. | It is a motordriven, indoor andoutdoortransportation vehiclewith the intended useto provide mobility toa disabled or elderlyperson limited toa seated position. | S.E. |
| Use condition | indoor and outdooruse | indoor and outdooruse | indoor and outdooruse | S.E |
| Number of wheels | 4, including two frontwheels and two rearWheels | 4, including two frontwheels and two rearWheels | 4, including two frontwheels and two rearWheels | S.E |
| Function of wheels | Front wheels: drivenwheels suitable forrotation, acceleration,retrograde.Rear wheels: drivingwheels to control thespeed and direction | Front wheels: drivenwheels suitable forrotation, acceleration,retrograde.Rear wheels: drivingwheels to control thespeed and direction | Front wheels:driven wheelssuitable for rotation,acceleration,retrograde.Rear wheels: drivingwheels to control thespeed and direction | S.E |
| Movement controlmethod | By Joystick control | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on therearwheels | Direct drive on therear wheels | Direct drive onthe rear wheels | S.E |
| Brake system | Automatic electronicbrake system | Automaticelectromagneticbrake system | Automaticelectromagneticbrake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | ≤1.5 m | S.E |
| Maximum safeoperational inclinedegree | 3 ° | 9 ° | 8 ° | Analysis |
| Armrest | ABS | PU | PU (polyurethane) | Analysis |
| Battery charger | Off-board chargerInput: 100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A; | Off-board chargerInput: 100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A; | Off-board chargerInput: 100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A; | S.E |
| Main frame material | Aluminum Alloy | Carbon fiber material | Aluminum Alloy | Analysis |
| Back cushion | Polyester fabric | Polyester fabric | linen cloth filledwith PU foam | S.E |
| Seat cushion | Polyester fabric | rubber patch clothand Oxford fabric | linen cloth filledwith PU foam | Analysis |
| Overall Dimension(lengthwidthheight) | HBLD3-B model:960580890 mmHBLD3-E model:1090640900 mm | 940610960mm | N/A | S.E |
| Folded Dimension(lengthwidthheight) | HBLD3-B model:890600380 mmHBLD3-E model:730350950 mm | 720310610mm | N/A | S.E |
| Front wheelsize/type | 7" x 1.75"/PU Solidtire | 7" x 1.75"/PU Solidtire | 7" x 1.75" /PU Solidtire | S.E |
| Rear wheel size/type | 12" x 2.125"pneumatic tire | 8.5" x 2" / PU Solidtire | 8"x1.95" /PU solidtires | Analysis |
| Max speed forward | 6.12 km/h | Up to 6 km/h(1.6m/s), adjustable | 3.75 mph (6 km/h) | Analysis |
| Max Speedbackward | Less than 3 km/h(0.8m/s) | Less than 3 km/h(0.8m/s) | N/A | S.E |
| Max loading weight | 100 kg | 136 kg | 136 kg | Analysis |
| Battery | Li-ion battery pack;rechargeable, 24 VDC5.2 Ah*2 | Li-ion battery pack;rechargeable, 24VDC 12Ah | Lithium-ion,24V6Ah, 6Ah x24 VDC | Analysis |
| Maximumdistanceof travel on the fullycharged battery | 20km | 15 km | 20km | Analysis |
| Motor | Brushless DC motor;24VDC; 150W; 2pcs | Brushless DC motor;24VDC; 250W; 2pcs | Brushless DC motor180W x 24 VDC x 2pcs | S.E |
| Electronic controller | Brushless dual-driverocker controller | Brushless dual-driverocker controller | Brushless dual-driverocker controller | S.E |
| Turning radius | HBLD3-B model: 875mmHBLD3-E model:1050 mm | 900 mm | 800 mm | Analysis |
| Maximum obstacleclimbing | 20mm | 40 mm | 20mm | Analysis |
Table 1 General Comparison
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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China
Difference analysis:
The design and technological characteristics of the Electric Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Main frame material, Armrest, Seat cushion, Rear wheel size/type, Max speed forward, Max loading weight, Battery,Maximum distance of travel on the fully charged battery, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO 7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K220747).
Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO
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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China
10993 series.
Table 2 Safety comparison
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5, ISO10993-10 andISO 10993-23 requirements. | All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 & IEC 60601-2-1 | ISO7176-21 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 3 Safety comparison
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification. | The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification. | S.E. |
| ISO7176-2 | The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification. | The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification. | The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification. | S.E. |
| ISO7176-4 | The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification. | The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5 | The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5 | S.E. |
| ISO7176-6 | The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6 | The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6 | S.E. |
| ISO7176-7 | The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7 | The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7 | S.E. |
| ISO7176-8 | All test results meet therequirements in Clause 4 of ISO7176-8 | All test results meet therequirements in Clause 4 of ISO7176-8 | S.E. |
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| 1188 Xiangyang Road, Zhuanqiao, Minnang District, Shanghai 201108, P. R. China | |||
|---|---|---|---|
| ISO7176-9 | The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10 | The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10 | S.E. |
| ISO7176-11 | The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11 | The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved | The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14 | All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15 | The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15 | S.E. |
| ISO7176-16/ISO 16840-10 | The performance of resistance toignition meet the requirements ofISO 16840-10 | The performance of resistance toignition meet the requirements ofISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | S.E. |
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair, models: HBLD3-E, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220747.
§ 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).