(86 days)
Not Found
No
The description details a standard electric wheelchair with joystick control and does not mention any AI or ML components or functionalities.
No.
The device is a power wheelchair intended for mobility assistance, not for therapeutic treatment of a disease or condition.
No
The device is a power wheelchair, intended to provide mobility to disabled or elderly individuals; it does not perform any diagnostic functions.
No
The device description explicitly states it consists of a "wheelchair main body and the electrical part," detailing physical components like a frame, wheels, motors, brakes, and a battery. While it includes an "electronic control" and "controller," these are integral parts of the physical hardware, not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The W5905 Power Wheelchair is a mobility device designed to transport individuals with mobility limitations. It does not analyze any biological specimens.
- Intended Use: The intended use is clearly stated as providing mobility, not performing diagnostic tests.
- Device Description: The description focuses on the mechanical and electrical components for movement and control, not on any analytical or testing functions.
Therefore, based on the provided information, the W5905 Power Wheelchair falls under the category of a mobility aid or medical device for transportation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The W5905 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. This product is suitabled people with mobility difficulties and elderly people.
Product codes
ITI
Device Description
The subject Power Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling.
The subject Power Wheelchair is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.
The subject Power Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a seat cushion, a safety belt, two rear driving wheels and two front wheels. The electrical part is composed of two motors, two brakes, a li-ion battery, a controller and an off-board charger.
The device is powered by a Li-ion battery (24V 12Ah) with 15 Km 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. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake.
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 or elderly person limited to a seated position; indoor and outdoor use.
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
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 standards including ISO 10993 series for biological evaluation, ISO 7176 series for wheelchairs (static and dynamic stability, braking effectiveness, energy consumption, dimensions, speed, acceleration, deceleration, seating/wheel dimensions, strengths, climatic tests, obstacle-climbing, test dummies, friction coefficient, power and control systems, information disclosure, ignition resistance, electromagnetic compatibility, set-up procedures, batteries and chargers), Risk Analysis developed in accordance with ISO 14971:2019, Software evaluation, and Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. No clinical or animal study was conducted, and clinical testing was not required to demonstrate substantial equivalence.
Key results: The W5905 power wheelchair complied with all listed standards. The instructions for use, design, and technological characteristics are similar to the predicate device. Mainframes are folded similarly. Controller and driving system design principles are the same and meet ISO 7176-14:2008. Software validation was carried out on both control systems. Brake system and speed control are designed similarly and meet ISO 7176-3:2012. Slight differences in maximum obstacle climbing and maximum safe operational incline do not impact safety or effectiveness and meet ISO 7176-10:2008. Biocompatibility of both devices meets ISO 10993-5:2009 & ISO 10993-10:2010. Flame retardant test of seat cushion and armrest for both devices is carried out according to ISO 7176-16.
Key Metrics
Braking distance: ≤1.5m
Maximum distance of travel on the fully charged battery: 15km
Maximum speed forward: 1.7 m/s (6 km/h)
Maximum speed backward: 0.7m/s
Minimum braking distance from maximum speed: Forward:0.8m
Max loading weight: 136 kg
Maximum safe operational incline degree: 9°
Turning radius: 1200mm
Maximum obstacle climbing: 40mm
Predicate Device(s)
K202482 Y207 Electric Wheelchair JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
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).
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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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
July 1, 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: K221026
Trade/Device Name: W5905 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 6, 2022 Received: April 6, 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) K221026
Device Name W5905 Power Wheelchair
Indications for Use (Describe)
The W5905 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. This product is suitabled people with mobility difficulties and elderly people.
| 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
(As requirement by 21 CFR 807.92)
Date prepared: 21*, March, 2022
A. Applicant:
Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China. Contact: Leo Zheng Title: General Manager Tel: +86 18358936043 Email: snail821@163.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name: W5905 Power Wheelchair Device Model: W5905
Regulatory Information K221026 Classification Name: Wheelchair, Powered Classification: Class II Product code: ITI Regulation Number: 21 CFR 890.3860 Review Panel: Physical Medicine C. Predicate device: K202482 Y207 Electric Wheelchair JIANGSU INTCO MEDICAL PRODUCTS CO., LTD
D. Device Description:
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The subject Power Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling.
The subject Power Wheelchair is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.
The subject Power Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a seat cushion, a safety belt, two rear driving wheels and two front wheels. The electrical part is composed of two motors, two brakes, a li-ion battery, a controller and an off-board charger.
The device is powered by a Li-ion battery (24V 12Ah) with 15 Km 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. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake.
E. Indication for Use
The W5905 Power Wheelchair 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. This product is suitable for disabled people with mobility difficulties and elderly people.
| Attribute | Subject Device | Predicate Device | Discussion/Conclusion | Indications for Use | The W5905 Power
Wheelchair | The Y207 Electric
Wheelchair | Same |
|------------------------------|---------------------------------------------------------|-----------------------------------------------|-----------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Zhejiang Innuovo
Rehabilitation Devices Co.,
Ltd. | JIANGSU INTCO
MEDICAL PRODUCTS
CO., LTD | / | Intended user | Disabled or elderly person
limited to a seated position | Disabled people with
mobility difficulties and
elderly people | Same |
| Proprietary
name, model | Power Wheelchair, W5905 | Electric Wheelchair, Y207 | / | Use condition | Indoor and outdoor use | Indoor and outdoor use | Same |
| Device
classification | Class II | Class II | Same | Number of
wheels | 4, including two front
wheels and two rear wheels | 4, including two front
wheels and two rear
wheels | Same |
| Classification
regulation | 21 CFR 890.3860 | 21 CFR 890.3860 | Same | Function of
wheels | Front wheels: driven wheels
suitable for rotation,
acceleration, retrograde
Rear wheels: driving wheels
to control the speed and
direction | Front wheels: driven wheels
suitable for rotation,
acceleration, retrograde
Rear wheels: driving wheels
to control the speed and
direction | Same |
| Product code | ITI | ITI | Same | Frame design | The frame of the wheelchair
is type capable of front and
rear close. The main part of
the frame can be folded for
saving space and convenient
storage and transportation.
The main frame is made of
carbon fiber. | The frame of the wheelchair
is type capable of front and
rear close. The main part of
the frame can be folded for
saving space and
convenient storage and
transportation. The main
frame is made of
high-quality aluminum
material. | Analysis:
The two wheelchairs have
same frame design of front
and rear close. The
difference on the frame
material will not cause
safety and effectiveness
concerns. |
| 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 intelligent | Automatic intelligent | Same | | | | |
F. Comparison of technological characteristics with the predicate device
5
6
| | electromagnetic
brake
system | electromagnetic
brake
system | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Braking
distance | ≤1.5m | ≤1.5m | Same |
| Battery | Li-ion battery; rechargeable,
24 VDC 12Ah | Li-ion battery pack;
rechargeable, 24 VDC
20Ah | Analysis:
Difference of battery
capacity between the
proposed and predicate
devices may cause
difference on working
hours of the devices in
fully charged status, which
will not impact on the safe
and effectiveness of the
proposed device. |
| Maximum
distance
of
travel on the
fully charged
battery | 15km | 20km | Analysis:
Difference of the
parameter is caused by the
rated capacity of battery,
which will not raise safe
and effectiveness
concerns. |
| Main frame
material | Carbon fiber | Aluminum alloy | Analysis:
Difference of the materials
will not raise safe and
effectiveness concerns. |
| Seat cushion | Polyester fabric | Nylon braided belt | The biocompatibility tests
have been conducted to
verify the safety and
effectiveness of the
material. |
| Armrest | Carbon fiber | PU (polyurethane) | verify the safety and
effectiveness of the
material. |
| Overall
dimension
(L×W×H) | 930mm×577mm×930mm | 1100mm×700mm×980mm | Analysis:
Difference on overall
dimension will only affect
the appearance of the
device but not affect the
safety and effectiveness of
the subject device. All |
| | | | safety and performance
have been validated with
the maximum rated weight
dummy or human occupant. |
| Folded
dimension
(L×W×H) | 325mm×577mm×790mm | 810mm×700mm×400mm | Analysis:
Difference on folded
dimension will not affect
safety and performance of
the subject device. |
| Ground
clearance | 70 mm | 160 mm | Analysis:
Difference on the
clearance will not not
affect safety and
performance of the subject
device. Performance tests
have been conducted
according to ISO 7176
series. |
| Front
wheel
size/type | 7"×2"/PU solid tire | 8"×2"/PU solid tire | Analysis:
Different sizes of front
wheel will not affect
safety and performance
of the subject device as all
related stability tests are
performed according to
standard ISO 7176 series. |
| Rear
wheel
size/type | 8"×2"/PU solid tire | 10"×3"/Pneumatic tire | Analysis:
Different sizes and
materials of rear wheel will
not affect the safety and
performance of the subject
device as all related
stability tests are performed
according to standard ISO
7176 series. |
| Max
speed
forward | 1.7 m/s (6 km/h) | 0-1.5m/s (5.4 km/h),
continuously adjustable | Analysis:
Slightly difference on the
parameter will not affect
the safety and
performance of the subject |
| Max
speed | 0.7m/s | 0.8m/s (2.88km/h) | performance of the subject |
| backward | | | device as all related
stability tests are
performed according to
standard ISO 7176 series. |
| Minimum
braking distance
from maximum
speed | Forward:0.8m | Forward: 1.0m | Analysis:
Shorter braking distance
in the subject device than
the predicate device, all
relevant tests are
performed according to
standard ISO 7176-3, no
safety and performance
will be affected. |
| Max loading
weight | 136 kg | 127kg (275 lbs) | Analysis:
Slightly difference on the
parameter will not affect
the safety and
performance of the subject
device as the related test
has been performed with a
dummy according to
standard ISO 7176 series. |
| Maximum safe
operational
incline degree | 9° | 8° | Analysis:
Slightly difference on the
parameter will not affect
the safety and
performance of the subject
device as the related test
has been performed
according to standard ISO
7176 series. |
| Battery charger | Off-board charger
Input:AC 100-240V, 50/60
Hz, 1.5A
Output: 24V dc, 2A
Charging time: 8-10 hours | Off-board charger
Input:100-240V, 50/60
Hz, 2.5A
Output:24V dc, 6A;
Charging time: 6 hours | Analysis:
Current difference will
impact charging time only,
which will not cause new
safety and effectiveness
concerns raised. |
| Motor | Brushless DC motor | Brushless motor; 24VDC; | Analysis: |
| | 250W x 24 VDC; 2 pcs | 200W; 2pcs | Slight difference on motor
power will not cause
different
performance.
Larger power will provide
more driving force, no
safety and effectiveness
concerns raised. |
| Electronic
controller | 35A
manufactured
by
Shanghai Micon Mechanical
& Electrical Co., Ltd. | newVSi ELECTRIC
WHEELCHAIR
CONTROL
SYSTEM, 50A
manufactured
by PG DRIVES
TECHNOLOGY LTD. | Analysis:
Difference on output
current will affect
charging time of the
subject device, which will
not cause safety and
effectiveness concerns. |
| Turning radius | 1200mm | 950mm | Analysis:
Larger turning radius will
bring more convenience for
the use environment. All
relevant tests have been
performed according to
standards ISO 7176 series,
the difference will not raise
any new safety and
effectiveness concerns. |
| Maximum
obstacle
climbing | 40mm | 50mm | Analysis:
Less distance in the
obstacle climbing will
not impact the safety
and effectiveness of the
subject device. |
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8
9
G. Summary of substantial equivalence discussion
The W5905 power wheelchair complied with the requirements of ISO 7176-2:2017, 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 7176-16:2012, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, IEC 62133-2:2017, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.
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The instructions for use, design and technological characteristics of the subject Power Wheelchair are similar to the predicate device. Mainframes of the two devices are folded by way of front and rear close. 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 has been 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 7176-10:2008.
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 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, 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 device do not raise new issues of safety or effectiveness.
H. Summary of Non-clinical Tests
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:
- A ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity A
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
-
ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- A ISO 7176-2:2017, Wheelchairs - Part 2 Determination of dynamic stability of electric wheelchairs
- A ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
- A ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- A ISO 7176-5: 2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
-
ISO 7176-6: 2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- ISO 7176-7: 1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions A
- A ISO 7176-8: 2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
- A 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 A powered wheelchairs
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- ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies A
- A ISO 7176-13: 1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- A ISO 7176-14: 2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- A 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
- A 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 A
-
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchair
- Risk Analysis developed in accordance with ISO 14971:2019 A
-
Software evaluation
- A Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014
I. Biocompatibility of Patient-contacting material
Biocompatibility of patient-contacting material are evaluated in accordance with ISO 10993-1: 2018. Although there are risks related to cytotoxicity, sensitization and irritation, the risk level is very low as the patient-contacting parts of the power wheelchair are made from materials in common use for other consumer products with a similar nature of contact, in addition, the product quality is controlled and managed by design, manufacturing, quality control, safety instruction, or warning information, hence the biological safety of the power wheelchair is acceptable without further biocompatibility testing on some parts contacted with the user during operation procedure of the product.
J. Summary of Clinical Testing
No clinical or animal study is available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.
K. Conclusion
The differences between W5905 power wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device power wheelchair is substantially equivalent to the legally marketed predicate device.