(114 days)
Not Found
No
The description focuses on mechanical and electrical components (motor, controller, battery, frame, wheels, joystick) and standard performance testing (ISO 7176 series). There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No.
This device is described as a transportation vehicle designed to provide mobility for disabled or elderly individuals limited to a seated position, functioning as a power wheelchair. Its purpose is to assist with mobility, not to treat or cure a medical condition.
No
Explanation: The device is described as a motor-driven transportation vehicle designed to provide mobility for disabled or elderly individuals. Its functions are related to movement (forward, backward, turn, speed, direction) and comfort (folding, detachable seat, armrest), with no mention of diagnosing conditions or analyzing biological data.
No
The device description explicitly details hardware components such as a frame, wheels, seat, armrest, lithium battery, motor, and controller. It also describes physical actions like folding and driving the wheelchair.
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 function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with mechanical and electrical components for movement. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological material. There is no mention of reagents, assays, or diagnostic procedures.
- Performance Studies: The performance studies focus on physical characteristics like stability, braking, range, and dimensions, which are relevant to a mobility device, not an IVD.
In summary, this device is clearly a power wheelchair intended for personal transportation and mobility assistance, not for diagnosing diseases or conditions through in vitro analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
ITI
Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 136KG. Only for one person sit.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device 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, ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014.
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 includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 27, 2024
Zhejiang Zhonglei Medical Technology Co. Ltd. Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K242308
Trade/Device Name: Power wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 30, 2024 Received: October 30, 2024
Dear Ariel Xiang:
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.
1
Page
2
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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 Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Power wheelchair
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."
4
510(K) Summary
Document Prepared Date: 2024/10//30
A. Applicant
Name : Zhejiang Zhonglei Medical Technology Co.Ltd Address : 1st floor, 2nd floor, No. 66, Dayuan Street, Nanmingshan Street, Liandu District, Lishui City, Zhejiang Province, China. Contact Person: Chengwei Ying Tel: +86 13958430301 Mail:594506983@gq.com
Submission Correspondent: Primary contact: Ms. Ariel Xiang Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email:shouqiu.xiang@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: Power wheelchair Common Name: Powered wheelchair Models: N6102
Regulatory Information Classification Name: Powered Wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860
5
Review Panel: Physical Medicine
C. Predicate device:
510Knumber: K230964 Device Name:Power Wheelchair Manufacturer:Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Indications for use of the device D.
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.
E. Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 136KG. Only for one person sit.
F. Comparison with predicate Device
| Table 1 General Comparison |
|---|
| ---------------------------- |
| Elements of Comparison | Subject Device | Predicate Device
(K230964) | Remark |
|------------------------|-------------------|-------------------------------|--------|
| Manufacturer | Zhejiang Zhonglei | Zhejiang Innuovo | -- |
6
| | Medical
Technology Co.Ltd | Rehabilitation
Devices Co.,Ltd | | Driving system | Direct drive on the
rear
wheels | Direct drive on the
rear
wheels | S.E |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|----------------------------------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual name | Power Wheelchair | Power Wheelchair | -- | Brake system | Automatic
electromagnetic
brake system | Automatic
electromagnetic
brake system | S.E |
| Model(s) | N6102 | N5909 | -- | Braking distance | 780mm | ≤1.5 m | Minor difference
on braking
distance will not
cause different
performance.
Shorter distance
for braking will be
more safety. |
| Classification | Class II | Class II | Same | Maximum safe
operationalincline
degree | 9 ° | 9 ° | S.E |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | Same | Armrest | Carbon fibers | T700 | 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. |
| Product code | ITI | ITI | Same | Main frame material | Carbon fiber
material | Carbon fiber
material | S.E |
| Indications for use | 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. | 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. | S.E. | Back cushion | Polyester fiber | Polyester fabric | S.E |
| Intended user | disabled or elderly
person limited to a
seated position. | disabled or elderly
person limited to a
seated position. | S.E. | Seat cushion | Polyester fiber | Polyester fiber | S.E |
| Use condition | indoor and outdoor
use | indoor and outdoor
use | S.E | Overall Dimension
(lengthwidthheight) | 950610960mm | 900580860mm | Minor difference
on wheelchair
dimension will not |
| Number of wheels | 4,including two
front wheels and
two rear Wheels | 4,including two
front wheels and
two rear Wheels | S.E | | | | |
| Function of wheels | Front
wheels:driv
en wheels
suitable for
rotation,
acceleration,
retrograde Rear
wheels: driving
wheels to control
the speed and
direction | Front
wheels:driv
en wheels
suitable for
rotation,
acceleration,
retrograde Rear
wheels: driving
wheels to control
the speed and
direction | S.E | | | | |
| Movement control | By Joystick control | By Joystick control | S.E | | | | |
7
8
| (lengthwidthheight) | | | cause different
performance. All
safety and
performance have
been validated
with the maximum
rated weight
dummy.
Analysis |
|---------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Front wheel size/type | 7" x1.78"/ PU
Solid tire
(180mm
x45mm) | 7" x 1.75"/PU Solid
tire | Minor difference
on dimension of
wheels will not
cause different
performance. |
| Rear wheel size/type | 9" x 2"/PU Solid
tire
(230mm
x50mm) | 8.5" x 1.8"/ PU
Solid tire | Minor difference
on dimension of
wheels will not
cause different
performance. |
| Max speed forward | 1.54 m/s (5.5km/h) | Up to 6 km/h (1.6
m/s), adjustable | Minor difference
on Max speed
forward of wheels
will not cause
different
performance. |
| Max loading weight | 136kg (≈300lbs) | 110kg (≈250lbs) | Difference on
loading weight will
not cause different
performance. All
safety and
performance have
been validated
with the maximum
loading weight. |
| Maximum distance of
travel on the fully charged
battery | 16.1km | 10 km | It is caused by the
size of the wheel,
will not cause
different
performance, The
further away the
better |
| Battery | | | |
| | li-ion battery pack
24V,10Ah, | li-ion battery pack
rechargeable, 24 VDC 10Ah | S.E |
| 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; | S.E |
| Motor | Brushless Eco-Drive,
24V,150W, 2pcs | Brushless DC motor; 24VDC; 150W; 2pcs | S.E |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | S.E |
| Turning Radius | 900mm | 900 mm | S.E |
| Maximum obstacle climbing | 25mm | 40 mm | Minor difference on obstacle climbing will not cause new safety and effectiveness concerns. |
9
Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting | ||
| materials are compliance | |||
| with | |||
| ISO10993-5 ,ISO10993-10 | |||
| ,ISO10993-23 requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and ISO10993-10 | |||
| requirements. | S.E. | ||
| EMC | ISO7176-21 and IEC 60601- | ||
| 1-2 | ISO7176-21 and IEC 60601-1- | ||
| 2 | S.E. | ||
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and | |||
| labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
| Item | Proposed Device | Predicate Device | Results |
| ISO7176-1 | The Static stability has been | ||
| determined after the testing | |||
| according to the ISO 7176-1, | |||
| and test results meet its | |||
| design specification. | The Static stability has been | ||
| determined after the testing | |||
| according to the ISO 7176-1, | |||
| and test results meet its | |||
| design specification. | S.E. | ||
| ISO7176-2 | The dynamic stability has | ||
| been determined after the | |||
| testing according to the ISO | |||
| 7176-2, and test results meet | |||
| its design specification. | The dynamic stability has | ||
| been determined | |||
| after the testing according to | |||
| the ISO 7176-2, and test | |||
| results meet its design | |||
| specification. | S.E. | ||
| ISO7176-3 | The effectiveness of brakes | ||
| has been determined after the | |||
| testing according to the ISO | |||
| 7176-3, and test results meet | |||
| its design specification. | The effectiveness of brakes | ||
| has been | |||
| determined after the testing | |||
| according to the ISO 7176-3, | |||
| and test results meet its | |||
| design specification. | S.E. | ||
| ISO7176-4 | The theoretical distance range | ||
| has been determined after | |||
| the testing according to the | |||
| ISO 7176-4, and test results | |||
| meet its design specification. | The theoretical distance range | ||
| has been determined after | |||
| the testing according to the | |||
| ISO 7176-4, and test results | |||
| meet its design specification. | S.E. | ||
| ISO7176-5 | The dimensions, mass has | ||
| been determined after the | |||
| testing according to the ISO | |||
| 7176- 5. | The dimensions, mass has | ||
| been determined after the | |||
| testing according to the ISO | |||
| 7176- 5. | S.E. | ||
| ISO7176-6 | The dimensions, mass has | ||
| been determined after the | |||
| testing according to the ISO | |||
| 7176- 5. | The dimensions, mass has | ||
| been determined after the | |||
| testing according to the ISO | |||
| 7176- 5. | S.E. | ||
| ISO7176-7 | The seating and wheel | ||
| dimensions has been | |||
| determined after the testing | |||
| according to the ISO 7176-7. | The seating and wheel | ||
| dimensions has been | |||
| determined after the testing | |||
| according to the ISO 7176-7. | S.E. | ||
| ISO7176-8 | All test results meet the | ||
| requirements in Clause 4 of | |||
| ISO 7176-8. | All test results meet the | ||
| requirements in Clause 4 of | |||
| ISO 7176-8. | S.E. | ||
| ISO7176-9 | 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 testsspecified in Clause | |||
| 8 of ISO 7176-9. | 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. | S.E. | ||
| ISO7176-10 | The obstacle-climbing ability | ||
| of device has been | |||
| determined after the testing | |||
| according to the ISO 7176-10. | The obstacle-climbing ability | ||
| of device has been determined | |||
| after the testing according to | |||
| the ISO 7176-10. | S.E. | ||
| ISO7176-11 | The test dummies used in the | ||
| testing of ISO 7176 series are | |||
| meet the requirements of ISO | |||
| 7176-11. | The test dummies used in the | ||
| testing of ISO 7176 series are | |||
| meet the requirements of ISO | |||
| 7176-11. | S.E. | ||
| ISO7176-13 | The coefficient of friction of | ||
| test surfaces has been | |||
| determined, which could be | |||
| used in other 7176 series tests | |||
| involved. | The coefficient of friction of | ||
| test surfaces has been | |||
| determined, which could be | |||
| used in other 7176 series tests | |||
| involved. | S.E. | ||
| ISO7176-14 | All test results meet the | ||
| requirements in Clause 7, 8, 9, | |||
| 10, 11, 12, 13, 14, 15, 17 of | |||
| ISO 7176-14. | All test results meet the | ||
| requirements in Clause 7, 8, 9, | |||
| 10, 11, 12, 13, 14, 15, 17 of | |||
| ISO 7176-14. | S.E. | ||
| ISO7176-15 | The test results shown that | ||
| information | The test results shown that | ||
| information | S.E. | ||
| disclosure, documentation | |||
| and labelling of device meet | |||
| the requirements of ISO7176- |
-
| disclosure, documentation and
labelling of device meet the
requirements of ISO
7176-15. | |
| ISO16840-
10:2021 | The performance of resistance
to
ignition meet the requirements | The performance of resistance
to
ignition meet the requirements | S.E. |
| | of ISO 16840-10:2021. | of ISO 16840-10:2021. | |
| ISO 7176-
21/IEC60601-
1-2 | The EMC performance results
meet the requirements of ISO
IEC60601-1-2. | The EMC performance results
meet the requirements of ISO
7176-21&IEC60601-1-2. | S.E. |
| ISO7176-25 | The performance of batteries
and charger of device meet
the Requirements in Clause 5
and 6 of ISO 7176-25. | The performance of batteries
and charger of device meet
the Requirements in Clause
5and 6 of ISO 7176-25. | S.E. |
10
11
12
G. Substantial Equivalence Discussion
The subject device 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, ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014.
The intended uses for both devices are the same. Mainframes of 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 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 obstacle climbing 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. Therefore, both devices are assured to be under the same safety level.
The all rest different between the subject device and predicate device can proved the safety or effectiveness by the ISO 7176 series support reports.
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.
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.
13
H. Substantially Equivalency Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, K230964 Power Wheelchair from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.