K Number

Device Name

Portable Folding Electric Wheelchair (Model: DC01)

Manufacturer

Anhui JBH Medical Apparatus Co., Ltd

Date Cleared

2022-05-06

(304 days)

Product Code

ITI

Regulation Number

890.3860

Intended Use

The wheelchair (Model: DC01) 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.

Device Description

The device is Electric Wheelchair, model no. is DC01. An electric wheelchair is a four-wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The electric wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway. The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion. The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113463

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description of the device and its functionality, including the "automatic intelligent electromagnetic brake system," does not mention or imply the use of AI or ML. The "intelligent" aspect likely refers to a simple sensor or logic that activates the brake when the joystick is released, not a learning or adaptive system.

Therapeutic

No.
The device's intended use is to provide mobility. While it assists disabled or elderly individuals, it does not directly treat or cure a disease or condition, nor does it restore a bodily function in a therapeutic sense. It's a mobility aid, not a therapeutic intervention.

Diagnostic

The device is an electric wheelchair, designed to provide mobility for disabled or elderly individuals. It does not perform any diagnostic functions like detecting, monitoring, or diagnosing a medical condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like motors, wheels, frame, battery, and a joystick, indicating it is a hardware device with integrated software for control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as providing mobility to disabled or elderly individuals. This is a physical function, not a diagnostic one.
Device Description: The description details a mechanical and electrical device for transportation. It does not involve analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
Performance Studies: The performance studies listed are related to the physical and electrical performance and safety of a wheelchair (stability, braking, speed, strength, etc.), not diagnostic accuracy or analytical performance.

In summary, the device is a mobility aid, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The wheelchair (Model: DC01) 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 (comma separated list FDA assigned to the subject device)

ITI

Device Description

The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, electromagnetic brake system, battery box, controller and battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back cushion.

The device is powered by Li-ion Battery pack (24V 6Ah, 144Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

disabled people and elderly people / indoor and outdoor

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)

Study Type: Non-clinical testing (Performance testing-bench)
Key Results: The DC01 electric wheelchair complied with the requirements of various ISO standards: ISO 7176-1:2014, 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. Biocompatibility was also evaluated according to ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010, and the materials were found to be bio-safe. Specific tests included Risk Analysis (ISO 14971:2019), Software evaluation, determination of static stability, dynamic stability, brake effectiveness, energy consumption, dimensions, maximum speed, acceleration and deceleration, seating and wheel dimensions, static, impact and fatigue strength, climatic tests, obstacle-climbing ability, test dummies, coefficient of friction of test surfaces, power and control systems, information disclosure, documentation and labeling, electromagnetic compatibility. The differences between the subject device and the predicate device do not raise new safety or effectiveness concerns, and the performance testing confirmed the substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113463

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 6, 2022

Anhui JBH Medical Apparatus Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1401. No.1500. Century Ave. Pudong New District, Shanghai 200122 China

Re: K212092

Trade/Device Name: Portable Folding Electric Wheelchair, Model DC01 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 5, 2022 Received: February 10, 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

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,

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

Enclosure

Indications for Use

510(k) Number (if known) K212092

Device Name

Portable Folding Electric Wheelchair (Model: DC01)

Indications for Use (Describe)

The wheelchair (Model: DC01) 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)

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K212092 510(k) Summary

Name: Anhui JBH Medical Apparatus Co., Ltd

Address: No. 116 qicang Road, Mingguang City, Chuzhou, Anhui, China

Name of contact person: Yang Dandan

Tel: 0086-18936033123

Fax: 0086-550-8106688

Date prepared: 2021/06/30

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

I. Device

Device trade name: Portable Folding Electric Wheelchair

Device model: DC01

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

II. Predicate device

K113463, PL001 power wheelchair, SUZHOU KID MEDICAL APPLIANCE CO., LTD. page 1 of 9

III. Device description

IV. Indication for use

The wheelchair (Model: DC01) 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.

Attribute	Subject device	Predicate device	Discussion/Conclusion
Manufacturer	Anhui JBH Medical
Apparatus Co., Ltd	SUZHOU KD Medical
Appliance Co. Ltd.	/
Proprietary
name, model	Electric Wheelchair, DC01	Power wheelchair, PL001	/
510(k) number	K212092	K113463	/
Device
classification
name	Class II	Class II	Same
Classification	21 CFR 890.3860	21 CFR 890.3860	Same
Attribute
regulations	Subject device	Predicate device	Discussion/Conclusion
Product code	ITI	ITI	Same
Similarities
Intended user	disabled people and
elderly people	disabled or elderly person	Same
Indication for
use	The wheelchair (Model:
DC01) 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.	They are motor driven,
indoor and outdoor
transportation vehicle with
the intended use to provide
mobility to a disabled or
elderly person limited to a
seated position.	Same
Use condition	indoor and outdoor use	indoor and outdoor use	Same
Number of
wheels	4, including two front
wheels and two rear
wheels	4, including two pivoting
casters and two rear drive
wheels	Same
Function of
wheels	Front wheels: driven
wheels suitable for
rotation, acceleration,
retrograde
Rear wheels: driving
wheels to control the speed
and direction	Two pivoting casters:
driven wheels suitable for
rotation, acceleration,
retrograde
two rear drive wheels:
driving wheels to control
the speed and direction	Same
Movement
control
method	By Joystick control	By Joystick control	Same
Driving
system	Direct drive on the rear
wheels	Direct drive on the rear
wheels	Same
Brake system	Smart Electromagnetic
brake	Intelligent regenerative
Electromagnetic brake	Same
Electronic
controller	Dual Drive Controller for
Brushless Motor	Brushless dual-drive
rocker controller	Same
Motor	Brushless DC motor
180W x 24 VDC x 2 pcs	Brushless DC motor; 24
VDC; 180 W; 2 pcs	Same
Armrest	PU	PU	Same
Max speed
forward	3.75 mph (6 km/h)	Up to 6 km/h (3.75 mph),
variable	Same
Maximum
distance of
travel on the
fully charged
battery	20 km	20 km	Same
Turning
Radius	800 mm	31.5" (800 mm)	Same
Differences
Frame design
and material	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 material.	The frame of the
wheelchair is type of
aluminum frame with front
and rear folding structure;
Up-and-down turnable
handrail, front and rear
adjustable armrest. The
main frame is made of
aluminum alloy material.	both of the wheelchair
can be folded in the
way of front and rear
folding type.
Minimum
braking
distance from	Forward: 0.5 m	Forward: 1.5 m	shorter braking
distance in the subject
device than the
Attribute	Subject device	Predicate device	Discussion/Conclusion
maximum speed			predicate device, all relevant tests are performed according to standard ISO 7176-3, no safety and performance will be affected.
Battery	Lithium-ion, 24V6Ah, 6Ah x 24 VDC	Li-ion, Rechargeable; 24 VDC 20Ah	Same rated voltage, as for difference on power capacity, both batteries are tested according to standard IEC 62133-2, no differences of batteries between both devices will affect the safety and performance of the subject device.
Battery charger	Off-board charger
Input: 100-240Vac, 50/60Hz, 1.5 A;
output: DC 24V, 2A,	Off-board, Automatic Type
Input: 110-220 V / 50-60 Hz,
Output: 24 Vdc, 2A	More wide range of input voltage in the device which will not cause new safety and effectiveness concerns raised.
seat cushion/back cushion	linen cloth filled with PU foam	PU foam covered by nylon fabric cloth	Different surface material in contact with the driver, the biocompatibility evaluation is performed on both devices, such difference will not affect the safety and performance of the subject device
Maximum safe operational incline degree	8 °	9 °	Minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated according to standard ISO 7176 series.
Max loading weight	120 kg (264 lbs)	114 kg (251 lbs)	Minor difference on loading weight will not cause different performance as all performance tests are performed according to standard ISO 7176 series
Front wheel size/type	7" x 1.75" /PU Solid tire	6"x 2"/PU Solid tire	different size of driven wheel will not affect safety and performance of the subject device as all related stability tests are performed
Attribute	Subject device	Predicate device	Discussion/Conclusion
Rear
wheel
size/type	8"x1.95" /PU solid tires	8" x 2.4"/PU Solid tire	according to standard
ISO 7176 series.
different size of driving
wheel will not affect
safety and performance
of the subject device as
all related stability tests
are performed
according to standard
ISO 7176 series.
Maximum
obstacle
climbing	20 mm	1.2" (30 mm)	less distance in the
obstacle climbing will
not impact the safety
and effectiveness of the
subject device.

V Comparison of technological characteristics with the predicate device

Summary of substantial equivalence discussion VI.

The DC01 electric wheelchair complied with the requirements of ISO 7176-1:2014, 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, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.

The intended uses for both devices are totally same. Mainframes of two devices are folded by way of front and rear close, although the locking structure for both devices are different from each other, the folding principle is the same. As for different frame materials used and minor difference on safe operational incline degree for both devices, considering all safety and performance tests are carried out on the subject device with favorable result, such difference will not affect the safety and performance of the subject device. 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 speed 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 7176-2:2017, ISO 7176-10:2008. The biocompatibility of the subject device is evaluated according to standard ISO 10993-1 and meet the requirements accordingly.

All seat cushion/back cushion and armrest are made of flame retardant material for both devices.

Therefore, the subject device is 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 device do not raise new issues of safety or effectiveness.

VII. Summary of non-clinical testing (Performance testing-bench)

The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

. Risk Analysis developed in accordance with ISO 14971:2019.
. Software evaluation
ISO 7176-1:2014 Wheelchairs Part 1: Determination of static stability .
. ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes ●
ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and ● scooters for determination of theoretical distance range
. ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
. ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs Part 7: Measurement of seating and wheel dimensions .
ISO 7176-8:2014 Wheelchairs Part 8: Requirements and test methods for static, impact and . fatigue strength
. ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of . electrically powered wheelchairs
. ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs Part 13: Determination of coefficient of friction of test .

surfaces.

. ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
. ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. ●
IEC 62133-2:2017 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

VIII. Biocompatibility of patient-contacting material

Biocompatibility of patient-contacting material are evaluated in accordance with ISO 10993-1: 2018. All parts of the wheelchair surface in contact with user skin are patient contact parts for the electric wheelchair. The biocompatibility tests are carried out on patient-contact materials, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010). The test results show all materials used are bio-safe. Below is the summary table:

| Component name | Material | Direct contact/
indirect contact | Contact
body | Contact
duration | Evaluation tests |
|---------------------------|---------------------------|-------------------------------------|------------------------|---------------------|---------------------------------------------|
| Seat cushion
(surface) | linen cloth | Direct | intact skin
surface |