(59 days)
Not Found
No
The description focuses on basic electromechanical components and control via a joystick with an automatic braking system. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typically associated with AI/ML-powered devices.
No
The device is a power wheelchair, intended to provide mobility. It does not treat or cure a disease or condition.
No
The device is described as a motor-driven transportation vehicle to provide mobility, not to diagnose medical conditions.
No
The device description explicitly lists numerous hardware components (front wheel, drive wheel, frame, controller, motor, armrest, etc.) and is a physical transportation vehicle, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to disabled or elderly persons. This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details a mechanical and electrical device for transportation, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
- Performance Studies: The performance studies focus on safety and mechanical standards (ISO, IEC), which are typical for medical devices providing physical support, not IVDs.
In summary, the Power Wheelchair is a mobility aid, not a device used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Power Wheelchair 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.
Product codes
ITI
Device Description
This Power wheelchair 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, push-handle, backrest, seat cushion, pedal, battery box and charger.
The device is powered by 2 Li-ion Battery pack (24V 10Ah, 240Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board 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, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2019.
- Software validation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric 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 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 strength
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
- ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 12, 2022
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K220740
Trade/Device Name: Power Wheelchair, W5907 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 14, 2022 Received: March 14, 2022
Dear Ivy 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name Power Wheelchair, W5907
Indications for Use (Describe)
The Power Wheelchair 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)
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3
510(k) Summary
l. SUBMITTER
Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China
Name of contact person: Leo Zheng
Telephone: +86 18358936043
Fax: +86-579-89327232
Date prepared: 2022-05-05
II. Device
Device trade name: Power Wheelchair, W5907 Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI
III. Predicate device
K113463 Power wheelchair, PL00I
SUZHOU KD Medical Appliance Co. Ltd.
IV. Device description
This Power wheelchair 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, push-
handle, backrest, seat cushion, pedal, battery box and charger.
The device is powered by 2 Li-ion Battery pack (24V 10Ah, 240Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
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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, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
V. Indication for use
The Power Wheelchair 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.
| VI. Comparison of technological characteristics with the predicate device | |||||
|---|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------------------------------- | -- | -- |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | SUZHOU KD Medical Appliance Co. Ltd. | / |
| Proprietary name, model | Power Wheelchair, W5907 (Q50 R Carbon) | power wheelchair, PL00I | / |
| 510(k) number | K220740 | K113463 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | |||
| Indication for use | The Power Wheelchair 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. | They are 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. | Same |
| Intended user | disabled people with mobility difficulties and elderly people | disabled or elderly person limited to a seated position | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear wheels | 4, including two pivoting casters and two rear drive wheels | Same |
| Function of wheels | Front wheels: driven | two pivoting casters: driven | Same |
| Attribute | Subject device | Predicate device | Discussion/ |
| Conclusion | |||
| wheels suitable for | |||
| rotation, acceleration, | |||
| retrograde | |||
| Rear wheels: driving | |||
| wheels to control the | |||
| speed and direction | wheels suitable for rotation, | ||
| acceleration, retrograde | |||
| two rear drive wheels: | |||
| driving wheels to control | |||
| the speed and direction | |||
| Movement control | |||
| method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rear | ||
| wheels | Direct drive on the rear | ||
| wheels | Same | ||
| Brake system | Automatic electromagnetic | ||
| brake system | Intelligent regenerative | ||
| Electromagnetic brake | Same | ||
| Braking distance | ≤1.5 m | Forward: 1.5m (59") at max | |
| speed | Same | ||
| Battery | li-ion battery pack; | ||
| rechargeable, 24 VDC | |||
| 10Ah *2pcs | Li-ion, Rechargeable; 24 | ||
| VDC 20Ah | Same | ||
| Maximum distance | |||
| of travel on the fully | |||
| charged battery | 20 km | 20 km | Same |
| Battery charger | Off-board charger | ||
| Input: 100-240V, 50/60Hz, | |||
| 1.5A, | |||
| Output: 24 Vdc, 2A; | Off-board, Automatic Type | ||
| Input: 110-220 V / 50-60 | |||
| Hz, | |||
| Output: 24 Vdc, 2A; | Same | ||
| Differences | |||
| Main frame material | Carbon fiber material | aluminum alloy | Different material used |
| for frame, that such | |||
| difference will not impact | |||
| the safety and | |||
| effectiveness of the | |||
| subject device as the | |||
| performance tests are | |||
| conducted according to | |||
| ISO 7176 series. The | |||
| carbon fiber material is | |||
| lighter and easy to carry. | |||
| back cushion | Polyester fabric | PU foam covered by nylon | |
| fabric cloth | different material used | ||
| for parts in contact with | |||
| user, which such | |||
| differences will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| Attribute | Subject device | Predicate device | Discussion/ |
| Conclusion | |||
| seat cushion | rubber patch cloth and | ||
| Oxford fabric | PU foam covered by nylon | ||
| fabric cloth | subject device as | ||
| biocompatibility tests are | |||
| carried out according to | |||
| ISO 10993 series. | |||
| 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 10993 series. | |||
| Armrest | T700 | PU | 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 10993 series. | |||
| Overall Dimension | |||
| (lengthwidthheight) | 923570928mm | 880570890mm | Minor difference on |
| wheelchair dimension | |||
| will not cause different | |||
| performance. All safety | |||
| and performance have | |||
| been validated with the | |||
| maximum rated weight | |||
| dummy. | |||
| Stowage Dimension | |||
| (lengthwidthheight) | 370570767mm | 720570400mm | |
| Front wheel | |||
| size/type | 6.5" x 1.5"/PU Solid tire | 6" x 2" /PU Solid tire | Minor difference on |
| dimension of driven | |||
| wheel will not cause | |||
| different performance. | |||
| Rear wheel size/type | 8.5"x 1.8"/ PU Solid tire | 8" x 2.4"/PU Solid tire | Minor difference on |
| dimension of driving | |||
| wheel will not cause | |||
| different performance. | |||
| Max speed forward | Up to 6 km/h (1.6 m/s), | ||
| adjustable | Up to 6 km/h (3.75 mph), | ||
| variable | minor difference on max. | ||
| forwarding speed will not | |||
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Max backward Speed | Less than 3 km/h (0.4m/s) | 2.4 mph (3.84 km/h) | cause different performance. lower speed will be more safety. |
| lower speed on max. backward speed will be more safety. | |||
| Max loading weight | 136kg (~300 lbs) | 114 kg (251 1bs) | Difference on loading weight will not cause different performance. more loading weight provide more convenient and stable performance for the transportation. |
| Maximum safe operational incline degree | 8 ° | 9 ° | minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated according to standard ISO 7176 series. |
| Motor | Brushless DC motor; 24VDC; 250W; 2pcs | Brushless DC motor; 24 VDC; 180 W; 2 pcs | minor difference on motor power will not cause different performance. larger power will provide more driving force, no safety and effectiveness concerns raised. |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Similar controller is used, both the control system, including the joystick controller, the electromagnetic brakes and the user interface are similar. The joystick controls the directions |
| Attribute | Subject device | Predicate device | Discussion/ |
| Conclusion | |||
| 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. | |||
| Turning Radius | 765 mm | 31.5" (800 mm) | The minor difference in the turning radius is caused by different size of wheelchair and may cause a little bit inconvenience when it turns in a narrow space while the minor difference will not raise any new safety and effectiveness concerns. |
| Maximum obstacle | |||
| climbing | 40 mm | 1.2" (30 mm) | Longer distance in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
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VII. Summary of substantial equivalence discussion
The power wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001,
ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998,
ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO
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7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, 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/backrest 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.
VIII. Summary of non-clinical testing
A Performance testing-bench
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- . Risk Analysis developed in accordance with ISO 14971:2019.
- . Software validation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric
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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 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 strength
- ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- . ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- . ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- ISO 7176-16:2012 Wheelchairs -- Part 16: Resistance to ignition of postural support devices
- . ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
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A Biocompatibility of patient-contacting material
Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
IX. Summary of clinical testing
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.
X. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K113463.