Electric Wheelchair (XW-LY001)

K200423 · Yongkang Dingchang Industry & Trade Co., Ltd. · ITI · Sep 22, 2021 · Physical Medicine

Device Facts

• Record ID: K200423
• Device Name: Electric Wheelchair (XW-LY001)
• Applicant: Yongkang Dingchang Industry & Trade Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended 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.

Device Story

Electric wheelchair (XW-LY001) provides mobility for disabled or elderly users. Device consists of foldable aluminum frame, seat, backrest, two rear driving wheels with DC motors/electromagnetic brakes, two front casters, and Li-ion battery. User operates device via joystick controller on control panel to adjust speed and direction. Releasing joystick triggers automatic deceleration and brake engagement. Device used indoors on good road conditions and small slopes. Output includes physical transport of user. Benefits include increased mobility and independence for individuals with limited walking ability. Healthcare provider/caregiver may assist with setup; user operates device independently.

Clinical Evidence

No clinical data. Bench testing only, including ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic, obstacle climbing, power/control systems, EMC) and ISO 10993 (biocompatibility).

Technological Characteristics

Aluminum alloy frame; DC24V 200W brushed motors; 25.2V 10.4Ah Li-ion battery; electromagnetic braking; joystick-based control system; foldable design; off-board charger. Complies with ISO 7176 series and IEC 62133. Patient-contacting materials (joystick knob, gaiter, enclosure, keypad) identical to predicate K202482; others tested per ISO 10993-5 and 10993-10.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor mobility assistance.

Regulatory Classification

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.

Predicate Devices

• Powered Wheelchair DYW30A(D09) (K170787)

Reference Devices

• Y207 Electric Wheelchair (K202482)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] 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: [phone] Email: [e-mail]

#### 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<br>Substantial Equivalence |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name, | Electric Wheelchair | Powered Wheelchair | -- |
| Manufacturer | YONGKANG<br>DINGCHANG INDUSTRY<br>& TRADE CO., LTD. | Nanjing Jin Bai He<br>Medical Apparatus Co.,<br>Ltd. | |
| Model(s) | XW-LY001 | DYW30A(D09) | -- |
| 510(k) number | K200423 | K170787 | -- |
| Frame Material | Aluminium alloy | Aluminium alloy | Same |
| Frame Design/Style | Foldable/<br>The device consists of a<br>foldable and non-rigid type<br>of power wheelchair base<br>with rear drive and 2<br>casters in the front and<br>two anti-tippers in the rear. | Foldable/<br>The device consists of a<br>foldable and non-rigid type<br>of power wheelchair base<br>with rear drive and 2<br>casters in the front and<br>two anti-tippers in the rear. | Similar |
| Folding Mechanism | A foldable seat frames<br>(The backrest could be<br>folded to seat) | A foldable seat frames<br>(The backrest could be<br>folded to seat) | Same |
| Product Structure | Consists of two foldable<br>armrests, a backrest, a<br>seat cushion, a foldable<br>frame, two rear driving<br>wheels with hub<br>motor/electromagnetic<br>brake assemblies, two<br>pivoting casters, a Li-ion<br>batteries, an off-board<br>battery charger, a control<br>panel, and an electric<br>motor controller. | Consists of two foldable<br>armrests, a seat belt, a<br>backrest, a seat cushion, a<br>foldable frame, two rear<br>driving wheels with hub<br>motor/electromagnetic<br>brake assemblies, two<br>pivoting casters, two Li-ion<br>batteries, an off-board<br>battery charger, a control<br>panel, and an electric<br>motor controller | The subject device has no<br>seat belt. Related<br>precautions and warnings<br>for use the device and the<br>information of operating<br>surface and max. slope<br>have clearly defined in the<br>user manual. |
| | | | |
| Length | 37.4" | 37.4" | Minor differences in<br>the dimensions will<br>not impact the safety<br>and effectiveness of<br>the substantial<br>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<br>not raise any new<br>safety and<br>effectiveness<br>concerns |
| Without batteries | 25.8kg / 55.6 lbs | Not publicly available | / |
| Controller | PG DRIVES<br>TECHNOLOGY LTD.,<br>newVSi | Changzhou Billon<br>Electronic Appliance Co.,<br>Ltd., WS-1 | Although different<br>controller<br>is used, both the control<br>system, including the<br>joystick controller, the<br>electromagnetic brakes<br>and<br>the user interface are<br>similar.<br>The joystick controls the<br>directions and speed of<br>movement, and when the<br>joystick is released, the<br>powered wheelchair will<br>slow down to stop and the<br>brakes will automatically<br>re-engage.<br>The controller also<br>provides the battery status<br>displaying and abnormal<br>condition displaying. Both<br>of the control systems are<br>evaluated according to |
| Drive Style<br>(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<br>Health Products Co.,Ltd | Jiangsu Feng Chi Green<br>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<br>(On-board/Off-board/<br>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<br>brake | Smart Electromagnetic<br>brake | Same |
| Minimum braking<br>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<br>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<br>wheels bring steadier<br>pivoting function than<br>predicate device. |
| Quantity | 2 | 2 | Same |
| Tire Pressure (if<br>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<br>Mass | 125kg/ 276 lbs. | 120kg/ 264 lbs. | Large loading weight<br>means more convenient<br>for the User. |
| Curb Climbing ability | 1.97 "(50mm) | 1.36" (34.5 mm) | The larger height in the<br>obstacle climbing will<br>not impact the safety<br>and effectiveness of the<br>subject device. |
| Ground clearance | 25mm | Not publicly available | / |
| Minimum Turning<br>Radius | ≤42.2"(≤1.2m) | 32.8" ( 833 mm) | The difference in the<br>turning radius will bring<br>more convenience when it<br>turns. The difference will<br>not raise any new safety<br>and<br>effectiveness<br>concerns. |
| Maximum Incline | 10 degrees…