(580 days)
No
The description details a standard electric wheelchair with a motor, battery, and controller, with no mention of AI or ML capabilities.
No.
The device is described as an indoor transportation vehicle to provide mobility, rather than to provide therapy for a medical condition.
No
The device description clearly states its purpose is "to provide mobility to a disabled or an elderly person limited to a seated position." It is an electric wheelchair, a mobility aid, not a device used to diagnose medical conditions or diseases.
No
The device description clearly outlines numerous hardware components including a motor, battery, frame, wheels, and a controller, indicating it is a physical device, not software-only.
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 disabled or elderly individuals. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical and electrical device for transportation. 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 specimen. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This electric wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
Product codes
ITI
Device Description
The Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller.
It is suitable to be used in low speed, good road condition and small slope.
The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The subject device has 8 inch front wheel and 12.5 inch rear wheel.
The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A.
Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is
§ 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" and the words "U.S. Food & Drug Administration".
September 22, 2021
Yongkang Dingchang Industry & Trade Co., LTD. % Boyle Wang Official correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K200423
Trade/Device Name: Electric Wheelchair (XW-LY001) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 11, 2021 Received: August 24, 2021
Dear Boyle 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,
Tushar Bansal -S
For Heather Dean, Ph. D 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
Enclosure
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Indications for Use
510(k) Number (if known) K200423
Device Name Electric Wheelchair (XW-LY001)
Indications for Use (Describe)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an 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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510(k) Summary
K200423
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD. Address: NO.99, HUAXI ROAD, XICHENG STREET, YONGKANG CITY, ZHEJIANG PROVINCE, 321300 CHINA Tel: 86- 13429055889 Fax: 86- 579-87321558 Contact: Tony Chen Date of Preparation: Sep.21.2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Electric Wheelchair Common name: Powered wheelchair Classification name: Wheelchair, Powered Model(s): XW-LY001
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate Device Information
Manufacturer: Nanjing Jin Bai He Medical Apparatus Co., Ltd. Device: Powered Wheelchair DYW30A(D09)
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510(k) number: K170787
5.0 Indication for Use Statement
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
6.0 Device Description
The Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller.
It is suitable to be used in low speed, good road condition and small slope.
The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The subject device has 8 inch front wheel and 12.5 inch rear wheel.
The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A.
Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is ≤1.5m
7.0 _Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 7176-1:2014 Wheelchairs – Part 1: Determination of static stability.
ISO 7176-2:2017 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered 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 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.
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs.
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of
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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 device.
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2014 Wheelchairs - Part 22 Set-up Procedures
ISO 7176-25:2013 First edition 2013-07-15Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
Biocompatibility of patient-contacting parts
Statement for Biocompatibility Certification
The Joystick knob, Joystick Gaiter, Enclosure Moulding(s), and Keypad of the Electric Wheelchair, XW-LY001 in its final finished form are identical to the Joystick knob, Joystick Gaiter, Enclosure Moulding(s), and Keypad of the Y207 Electric Wheelchair (JIANGSU INTCO MEDICAL PRODUCTS CO., LTD., K202482, clearance date 03/18/2021) in formulation, processing, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). The patient-contacting materials of Electric Wheelchair, XW-LY001 have the same nature of tissue contact and contact duration as the Y207 Electric Wheelchair.
Other patient-contacting material are carried out biocompatibility assessment in accordance with IS0 10993-1: 2018, including :
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
8.0 Clinical Test Conclusion
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Clinical testing was not required for this submission.
9.0 Comparison to Predicate Device and Conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of the model XW-LY001 Electric Wheelchair is 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.
| Characteristic | Subject Device | Predicate Device | Justification for
Substantial Equivalence |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name, | Electric Wheelchair | Powered Wheelchair | -- |
| Manufacturer | YONGKANG
DINGCHANG INDUSTRY
& TRADE CO., LTD. | Nanjing Jin Bai He
Medical Apparatus Co.,
Ltd. | |
| Model(s) | XW-LY001 | DYW30A(D09) | -- |
| 510(k) number | K200423 | K170787 | -- |
| Frame Material | Aluminium alloy | Aluminium alloy | Same |
| Frame Design/Style | Foldable/
The device consists of a
foldable and non-rigid type
of power wheelchair base
with rear drive and 2
casters in the front and
two anti-tippers in the rear. | Foldable/
The device consists of a
foldable and non-rigid type
of power wheelchair base
with rear drive and 2
casters in the front and
two anti-tippers in the rear. | Similar |
| Folding Mechanism | A foldable seat frames
(The backrest could be
folded to seat) | A foldable seat frames
(The backrest could be
folded to seat) | Same |
| Product Structure | Consists of two foldable
armrests, a backrest, a
seat cushion, a foldable
frame, two rear driving
wheels with hub
motor/electromagnetic
brake assemblies, two
pivoting casters, a Li-ion
batteries, an off-board
battery charger, a control
panel, and an electric
motor controller. | Consists of two foldable
armrests, a seat belt, a
backrest, a seat cushion, a
foldable frame, two rear
driving wheels with hub
motor/electromagnetic
brake assemblies, two
pivoting casters, two Li-ion
batteries, an off-board
battery charger, a control
panel, and an electric
motor controller | The subject device has no
seat belt. Related
precautions and warnings
for use the device and the
information of operating
surface and max. slope
have clearly defined in the
user manual. |
| | | | |
| Length | 37.4" | 37.4" | Minor differences in
the dimensions will
not impact the safety
and effectiveness of
the substantial
equivalence. |
| Width | 25.6" | 22.6" | |
| Height | 38.4" | 36.2" | |
| Seat Dimensions | | | |
| Width | 18.5" | Not publicly available | / |
| Depth | 16.9" | Not publicly available | / |
| Height | 19.3" | Not publicly available | / |
| Folded Dimensions | | | |
| Length | 30.5" | Not publicly available | / |
| Width | 25.6" | Not publicly available | / |
| Height | 13.8" | Not publicly available | / |
| Wheelchair Weight | | | |
| With batteries | 27.8kg / 61 lbs | 51.8" lbs. / 23.5 kg | The difference will
not raise any new
safety and
effectiveness
concerns |
| Without batteries | 25.8kg / 55.6 lbs | Not publicly available | / |
| Controller | PG DRIVES
TECHNOLOGY LTD.,
newVSi | Changzhou Billon
Electronic Appliance Co.,
Ltd., WS-1 | Although different
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 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 |
| Drive Style
(e.g., rear, mid, front) | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Motor Type | Brushed DC motor | Brushless DC motor | The minor differences will not impact the safety and effectiveness of the substantial equivalence. |
| Motor Output | DC 24V x 200W*2 pcs | 24 VDC *250W *2 pcs | |
| Batteries | Kunshan Hi-Fortune
Health Products Co.,Ltd | Jiangsu Feng Chi Green
Power Supply Co., Ltd. | The minor differences will not impact the safety and effectiveness of the substantial equivalence. |
| Quantity | 1pcs | 2 pcs | |
| Type | FH2410 | ITP2406 | |
| Chemistry | Lithium-ion | Lithium-ion | |
| Range per Charge | 15.5 miles (25km) | 11.2 miles (18 km) | There is a larger cruising range for the subject device. |
| Charger Type
(On-board/Off-board/
Carry-on) | Off-board | Off-board | Same |
| Input/Output Power | DC 25.2 V, 10.4 Ah | 24 VDC, 6 Ah | The minor differences will not impact the safety and effectiveness of the substantial equivalence. |
| Brake | Smart Electromagnetic
brake | Smart Electromagnetic
brake | Same |
| Minimum braking
distance and time | $≤$ 1.5 m,0.8s | 1m | Our minimum braking distance is a little bigger thanthe predicate device. There is no new safety and effectiveness concerns raised due to the difference |
| Max speed | | | |
| Forward | 3.75 mph (6 km/h) | 3.75 mph (6 km/h) | Same |
| Reverse | 1.79 mph(2.88 km/h) | 1.86 mph (3.0 km/h) | The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness. |
| Rear Wheels Size | 12.5" x 2.25"(320 x 57 mm) | 12.5" x 2.25"(320 x 57 mm) | Same |
| Quantity | 2 | 2 | Same |
| Tire Pressure (if
pneumatic) | 2kgf/m² | PU solid tire | / |
| Castors Size | 8"x1.97"(200 x 50mm) | 7"x1.77" (180 x 45 mm) | Larger sizes of front
wheels bring steadier
pivoting function than
predicate device. |
| Quantity | 2 | 2 | Same |
| Tire Pressure (if
pneumatic) | PU solid tire | PU solid tire | Same |
| Anti-tip Wheels | 2"x0.4"(48 x10mm) | Not publicly available | / |
| Removable (Yes/No) | No | No | Same |
| Maximum Occupant
Mass | 125kg/ 276 lbs. | 120kg/ 264 lbs. | Large loading weight
means more convenient
for the User. |
| Curb Climbing ability | 1.97 "(50mm) | 1.36" (34.5 mm) | The larger height in the
obstacle climbing will
not impact the safety
and effectiveness of the
subject device. |
| Ground clearance | 25mm | Not publicly available | / |
| Minimum Turning
Radius | ≤42.2"(≤1.2m) | 32.8" ( 833 mm) | The difference in the
turning radius will bring
more convenience when it
turns. The difference will
not raise any new safety
and
effectiveness
concerns. |
| Maximum Incline | 10 degrees | 8 degrees | Larger safe operational
incline of subject bring
more convenient for the
use environment |
| Footplates | Plastic | Not publicly available | / |
| Back Upholstery | Oxford cloth | PVC Vinyl | Biocompatibility evaluation
has been carried out
per ISO 10993-1.
There are no new safety
and effectiveness
concerns due to the
difference. |
| Armrest Type | Unadjustable | Not publicly available | / |
| Operating surface &
environment | Indoor | Indoor | Same |
| Additional Accessory | Electronic items: 1 year | Not publicly available | / |
Table1- General Device Characteristics Comparison Table
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8
9
10
Warranty
Frame: 5 years
Summary of substantial equivalence discussion:
The XW-LY001 Electric wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ાડભ 7176-5:2008, ISO 7176-6:2001, 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 62133:2012, 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/back 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, 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.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.