(168 days)
Not Found
No
The description focuses on basic electromechanical control via a joystick and an automatic braking system, with no mention of AI or ML terms or functionalities.
No
The device is described as an indoor transportation vehicle to provide mobility, not to treat, diagnose, or cure a disease or condition.
No
The device is described as a motor-driven transportation vehicle used for mobility, not for evaluating or diagnosing medical conditions.
No
The device description explicitly lists numerous hardware components including wheels, frame, controller, motor, battery, and charger, indicating it is a physical device with integrated software, 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 to provide mobility to a disabled or elderly person. This is a physical assistance device, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a mechanical and electrical device for transportation, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, assays, or laboratory procedures described.
The device is clearly a power wheelchair intended for personal mobility.
N/A
Intended Use / Indications for Use
The Power Wheelchair, W5521, is a motor driven, indoor 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, W5521, is a motor driven, indoor 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 and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 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 user 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 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
disabled people with mobility difficulties and elderly people
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)
Performance testing-bench:
- 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 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- 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.
- AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- Biocompatibility of patient-contacting material. The biocompatibility of the subject device was determined via the declaration of identical tissue-contacting materials to the predicate device, which evaluated biocompatibility according to the ISO 10993-5: 2009 and ISO 10993-10:2010 standards.
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 K220747.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
November 9, 2023
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: K231508
Trade/Device Name: Power Wheelchair, W5521 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 25, 2023 Received: May 25, 2023
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 (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/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.
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"
1
(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 OS 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.
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231508
Device Name Power Wheelchair, W5521
Indications for Use (Describe)
The Power Wheelchair, W5521, is a motor driven, indoor 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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4
510(k) Summary
K231508
l. SUBMITTER
Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China
Name of contact person: Grace Li
Telephone: +86 15924234767
Fax: +86-579-89327232
Email: Lss@kf-innuovo.com
Date prepared: 2023-11-08
II. Device
Device trade name: Power Wheelchair, W5521 Common name: Power Wheelchair Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI
III. Predicate device
Power Wheelchair, N5515B
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
IV. Device description
This Power wheelchair, W5521, is a motor driven, indoor 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 and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.
5
The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 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 user 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 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.
| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Zhejiang Innuovo
Rehabilitation Devices Co.,
Ltd. | Zhejiang Innuovo
Rehabilitation Devices
Co., Ltd. | / |
| Proprietary name,
model | Power Wheelchair, W5521 | Power Wheelchair,
N5515B | / |
| 510(k) number | K231508 | K220747 | / |
| 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. | 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. | Same |
| Intended user | disabled people with mobility
difficulties and elderly people | disabled people with
mobility difficulties and
elderly people | Same |
| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 6, including two front wheels
and two rear wheels, two
anti-tip wheels | 6, including two front
wheels and two rear
wheels, two anti-tip
wheels | Same |
| Function of wheels | Front wheels: driven wheels
suitable for rotation,
acceleration, retrograde
Rear wheels: driving wheels
to control the speed and
direction
Anti-tip wheels: preventing
the wheelchair from tipping
turning over when driving on
the slope. Non-adjustable. | Front wheels: driven
wheels suitable for
rotation, acceleration,
retrograde
Rear wheels: driving
wheels to control the
speed and direction
Anti-tip wheels:
preventing the
wheelchair from tipping
turning over when driving
on the slope.
Non-adjustable. | Same |
| 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 | Automatic
electromagnetic
brake system | Same |
| Battery charger | Off-board charger
Input: 100-240V, 50/60Hz,
1.5A,
Output: 24 Vdc, 2A; | Off-board charger
Input: 100-240V,
50/60Hz, 1.5A,
Output: 24 Vdc, 2A; | Same |
| back cushion | Polyester fabric | Polyester fabric | Same |
| seat cushion | rubber patch cloth and
Oxford fabric | rubber patch cloth and
Oxford fabric | Same |
| Armrest | Polyurethane (PU) | Polyurethane (PU) | Same |
| Max loading weight | 136kg (≈300 lbs) | 136kg (≈300 lbs) | Same |
| Maximum obstacle
climbing | 40 mm | 40 mm | Same |
| Differences | | | |
| Main frame material | aluminum alloy | Carbon fiber material | Different material used
for frame, that such
difference will not impact |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Total mass | 25kg | 16kg | subject device as the performance tests are conducted according to ISO 7176 series.
Different frame material caused different weight of the wheelchair. This difference will not raise any new safety and effectiveness concerns. |
| Overall Dimension (lengthwidthheight) | 1040mmX600mmX1020mm | 940mmX610mmX960mm | Minor difference on wheelchair dimension |
| Stowage Dimension (lengthwidthheight) | 390mmX600mmX810mm | 720mmX310mmX610mm | will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Front wheel size/type | 7.8" x 1.9"/ PU Solid tire | 7" x 1.75"/PU Solid tire | Minor difference on dimension of driven wheel will not cause different performance. |
| Rear wheel size/type | 11.8" x 2.2"/ PU Solid tire | 8.5"x 2"/ PU Solid tire | |
| Max speed forward | Up to 5.47 km/h (1.52 m/s), adjustable | Up to 6 km/h (1.6 m/s), adjustable | minor difference on max. forwarding speed will not cause different performance. lower speed will be more safety. |
| Max Speed backward | Less than 3 km/h (0.9m/s) | Less than 3 km/h (0.5m/s) | minor difference on max. back warding speed will not cause different performance. |
| Maximum safe operational incline degree | 6° | 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 |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| | | | according to standard
ISO 7176 series. |
| Braking distance | ≤1 m | ≤1.5 m | minor difference on
braking distance will not
cause different
performance. Shorter
distance for braking will
be more safety. |
| Battery | li-ion battery pack;
rechargeable, 24 VDC 10Ah | li-ion battery pack;
rechargeable, 24 VDC 12Ah | minor difference on
battery capacity will not
cause different
performance. This
difference will not raise
any new safety and
effectiveness concerns. |
| Maximum distance
of travel on the fully
charged battery | 10km | 15 km | Minor difference on
travel distance will not
cause different
performance. This
difference will not raise
any new safety and
effectiveness concerns |
| Motor | Brush DC motor; 24VDC;
200W; 2pcs | Brushless DC motor;
24VDC; 250W; 2pcs | minor difference on
motor power will not
cause different
performance. Both of
the motors are
evaluated according to
standard ISO
7176-14:2008 and there
are no new safety and
effectiveness concerns
raised due to the
difference. |
| Electronic controller | Micon M7086 controller | Micon M7084 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 | 600 mm | 900 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 |
VI. Comparison of technological characteristics with the predicate device
6
7
8
9
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 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014.
10
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. Turning radius 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 flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10, while the predicate device is carried out according to the ISO 7176-16 test. Both of the two testing methods are recognized consensus standards for flammability resistance. 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 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 -
11
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 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- . 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.
- AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- A Biocompatibility of patient-contacting material
12
The biocompatibility of the subject device was determined via the declaration of identical tissue-contacting materials to the predicate device, which evaluated biocompatibility according to the ISO 10993-5: 2009 and ISO 10993-10:2010 standards.
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 K220747.