LERADO, Powered Wheelchair, DF4110 series include the devices with the same mechanic and electric controlling structure but with different colors of body and veneer. The LERADO Powered Wheelchair, DF4110 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat and is battery operated. The device can be disassembled for transportation, easily foldable and is provided with an off-board battery charger. The movement of the wheelchair is controlled by the rider who uses hand controls located at the top of the steering column.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LERADO Power Wheelchair, Model DF4110. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, the submission describes adherence to various ISO and ANSI/RESNA standards for powered wheelchairs, materials testing, and a comparison of specifications with a predicate device.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable or cannot be extracted directly from this type of regulatory submission for a powered wheelchair.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the standards the device claims to meet and by demonstrating performance comparable to the predicate device. The "reported device performance" are the specifications and compliance with these standards.

Acceptance Criteria (Standard Compliance / Specification)	Reported Device Performance (LERADO DF4110)
Electromagnetic compatibility (ANSI/RESNA WC Vol.2 Part 2: 2009)	Complies
Static Stability (ISO7176-1: 1999)	Complies
Electric Wheelchairs (General) (ISO7176-2: 2001)	Complies
Brake Effectiveness (ISO7176-3: 2003)	Complies (Electromagnetic brake)
Energy Consumption (ISO7176-4: 2008)	Complies (Continuous trip distance: 20km / 12.4 miles)
Overall Dimensions, Mass, Maneuvering Space (ISO7176-5: 2008)	Complies (L: 1040mm, W: 625mm, H: 1250mm; Total weight: 70.3 kg)
Maximum Speed, Acceleration, Retardation (ISO7176-6: 2001)	Complies (Max Speed: 6km/h (4mile/h))
Seating and Wheel Dimensions (ISO7176-7: 1998)	Complies (Seat depth: 410mm, Seat height: 530mm, Seat width: 475mm)
Static, Impact, and Fatigue Strengths (ISO7176-8: 1998)	Complies
Climatic Tests (ISO 7176-9: 2009)	Complies
Climbing Ability (ISO7176-10: 2008)	Complies (6°)
Test Dummies (ISO7176-11: 1992)	Complies
Coefficient of Friction of Test Surfaces (ISO7176-13: 1989)	Complies
Information Disclosure, Documentation, Labeling (ISO7176-15: 1996)	Complies
Maximum Loading	136 kgs (300 lbs)
Frame Material (CAS# 7439-89-6 for SPCC Steel)	High-Quality SPCC Steel Pipe
Seat Leather Fire Resistance (EN 1021-1/-2:2006 equivalent)	PVC Leather, Resistant to ignition source smouldering cigarette, and match flame
Upholstery Fabric & Foam Fire Resistance (ANSI/BIFMA X5.1-1993, ISO 8191-1/-2, ISO 7176-16)	Fabric and Foam, resistance to ignition
Tire Material (CAS# 101-68-8 for PU)	PU Solid Tire

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes compliance with international standards (ISO, ANSI/RESNA) which typically involve testing samples of the device, but the specific sample sizes used by the manufacturer for their internal testing or for the certification to these standards are not detailed. The manufacturer is LERADO Global (MACAO Commercial Offshore) Limited, based in Macau, China, suggesting the testing likely occurred in connection with their manufacturing operations, possibly with test labs in China or elsewhere. The nature of these tests (e.g., durability, stability) is generally prospective as they are performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this device submission. This document relates to a physical medical device (a powered wheelchair) and its performance against engineering standards, not to an AI/diagnostic algorithm where expert-established ground truth for a test set would be relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as it pertains to human interpretation/adjudication of data, which is not relevant for the performance testing of a powered wheelchair against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable in the context of this device. MRMC studies are used for diagnostic or AI-assisted interpretation, not for mechanical devices like wheelchairs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as there is no "algorithm only" component described for this powered wheelchair.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the established engineering standards and specifications (e.g., ISO 7176 series, ANSI/RESNA WC Vol.2, EN 1021, ANSI/BIFMA X5.1). The device's performance is measured against these objective, quantifiable standards.

8. The sample size for the training set

This is not applicable. Powered wheelchairs are physical devices that do not typically use "training sets" in the sense of machine learning algorithms. Their design and manufacturing processes might involve iterative testing and refinement, but this is distinct from an AI training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Lerado. The logo consists of the word "LERADO" in bold, sans-serif font. The "A" in "LERADO" is replaced by a black triangle. Below the word "LERADO" is the word "DESIGNS" in a smaller font.

Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

K130982 66 510(k) SUMMARY "

Date summary prepared:

December 31, 2013

Submitter's Name: LERADO Global (MACAO Commercial Offshore) Limited

Avenida Marciano Baotista, No.26-54b, 7 Andar, H7 Edif. Centro Com., Chong Fok Macau, China.

Name of Contact Person:

Dr. Jen, Ke-Min Tel: +852-5-2475605 Fax:+852-5-2379627 Email:ceirs.jen@msa.hinet.net

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

LERADO Power Wheelchair, DF4110 Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

ANSI / RESNA WC Vol.2 Wheelchair Part 2: Electromagnetic compatibility, 2009. .
· ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
ISO7176-2 Wheelchairs Part 2:Determination of electric wheelchairs, 2001.
· ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.

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Image /page/1/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in bold, sans-serif font, with a triangle in place of the letter "A". Below the word "LERADO" is the word "GROUP" in a smaller, sans-serif font. The logo is simple and modern, and the use of the triangle adds a touch of visual interest.

Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

· ISO7176-4 Wheelchairs Part 4:Determination of energy consumption of electric wheelchairs, 2008.
· ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
· ISO7176-6 Wheelchairs Part 6:Determination of maximum speed, acceleration and retardation of electric wheelchairs, 2001.
· ISO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 1998.
· ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
· ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009.
· ISO7176-10 Wheelchairs Part 10:Determination of the climbing ability of electric wheelchairs, 2008.
· ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
· ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
· ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.

Materials of the subject device:

Components	Materials	Test regulation
FRAME	High-Quality SPCC Steel Pipe	CAS# 7439-89-6
SEAT Leather	PVC Leather	EN 1021-1/-2:2006 Resistant toignition source smoulderingcigarette, and match flameequivalent
UPHOLSTERYFABRIC & LINING	Fabric and Foam	ANSI/BIFMA X5.1-1993,ISO 8191-1/-2, ISO 7176-16:resistance to ignition
TIRE	PU Solid Tire	CAS# 101-68-8

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Image /page/2/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in a bold, sans-serif font, with a triangular shape in place of the "A". Below the word "LERADO" is the word "GROUP" in a smaller font. The logo is black and white.

Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Con. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

Specifications of the subject device:

. Frame Material: High Quality SPCC Steel Pipe
Framework: Unfoldable
Controller: Dynamic Shark 40A ●
Motor output :
Motor: ●

Trade name: Chiapua Components Group

Type: GD35D-05T, DC24V Direct Current Carbon Brush Motor

Size: �88.5mm x 109mm

Output: 200W

RPM: 2955RPM

Battery: 35Ahx12Vx2pcs .
. Charger : 3A
Brake : Electromagnetic brake
Max Speed : 6km/h (4mile/h)
Continuous trip distance : 20km /12.4mile
Climbing ability:6°
Front wheel: 10" PU Solid tire
Rear wheel : 6" PU Solid tire
Seat depth : 410 mm (16.1" )
Seat height: 530 mm (20.9")
Seat width : 475 mm (18.7" )
Max loading: 136kgs(300lbs)
. Available color: black (body), red/yellow/blue (veneer)
Total weight:70.3 kgs / 155 lbs
. Ground clearance:48 mm / 1.9"
Turning diameter : 1,230 mm / 48.4"
Dimension ( LWH ): 1,040 * 625 * 1,250 mm

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Image /page/3/Picture/0 description: The image shows the logo for "LERADO DESIGNS". The logo is in black and white, with the word "LERADO" in large, bold letters. The letter "A" in "LERADO" is replaced by a triangle. Below the word "LERADO" is the word "DESIGNS" in smaller letters.

Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

Comparison table

ITEMS	PREDICATEDEVICE	SUBJECT DEVICE
BRAND NAME	LERADO	LERADO
MANUFACTURER	LERADO GROUP	LERADO GROUP
MODEL NO	PB Series	DF4110 Series
510K NO	K070433	K130982
INTENDED USE	The device isintended for medicalpurposes to providemobility to personsrestricted to a sittingposition.	SAME
Frame	Fixed (unfoldable)	SAME
Overall dimension
Overall length	650 mm / 25.59"	1,040 mm / 40.94"
Overall width	600 mm / 23.62"	625 mm / 24.60"
Weight limit	136 kgs / 300 lbs	SAME
Maximum speed	6.0 km/hr (4mile/h)	SAME
Electronicscontroller	Dynamic, DA50	Dynamic, Shark 40A
Batteries
QuantityTypeRange per charge	Two36Ah 12VDC36 km / 22.5 miles	Two35Ah 12VDC20 km / 12.4 miles
Suspension	Cross brace	SAME
Rear wheels	10" solid x 2"	6" PU solid tire
Casters	8" solid x 2"	10" PU solid tire
ITEMS	PREDICATEDEVICE	SUBJECT DEVICE
Footplates	ABS	SAME
Frame material	High-Quality SPCC SteelPipe	SAME
Motor
Trade name	Motion Technology Electric &Machinery Co., ltd.	Chiapua Components Group
Model number	EC82M	GD35D-05T
power	320W	200W
Type	24VDC Carbon-brush	24VDC Carbon-brush
Diameter	$Φ$ 82mm *149mm	$Φ$ 88.5mm * 109mm
Speed	4600 RPM	2955 RPM
Seat size
Width	46~~61 cm / 18~~24"	47.5 cm / 18.70"
Depth	46 cm / 18"	41 cm / 16.14"
Height	53~~58 cm / 21~~23"	53 cm / 20.86"
Incline	6 degrees	6 degrees
Backupholstery	Fabric	SAME
Armrest types	Flip-backward	SAME
WheelchairWeightw/batteries	87 kgs	70.3 kgs
ChargerModelVoltage	HIGH POWERHP8204B24VDC	HIGH POWERHP1211B124VDC
ITEMS	PREDICATEDEVICE	SUBJECT DEVICE
Wheel Lock	Push-to-Lock	SAME
Type of brake	Dynamic electromagneticbrake	SAME
Warranty	3 years: Main frame1 years: Controller / gearmotor / batteries w/oexhaustive and wearparts	SAME

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Image /page/4/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in a stylized font, with a triangle in place of the "A". Below the word is the text "LERADO GROUP" in a smaller font. The logo is black and white.

Avenida Marciano Baotista. No.26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

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Image /page/5/Picture/0 description: The image shows the word "LERADO" in a stylized font. The "A" in the word is replaced by a triangle. Below the word, there is a series of dots and dashes.

Avenida Marciano Baotista. No. 26-54b. 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

Substantial equivalence comparison discussion:

We know from the above table that the intended use between two devices is the same; and they are from the same LERADO group and the same manufacturer. Mainframes of two devices are not foldable and all meet the strength and fatigue tests, thus they are similar for the material aspects. The overall dimensions are similar. The weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and the warranty are all the same. Back upholstery material is also the same fabric.

Especially, the electronic systems of two devices, for instance the motor, batteries, and charger are from the same supplier, and both are UL-certified. For the electronic controller, the predicate device uses the Dynamic DA series and the subject device use Dynamic Shark series, and both are UL-certified. Thus the same safety level for the two devices is assured.

Incline capabilities for the two devices are the same. The subject device and the predicate device can both drive under 6 degrees of incline. We place the limit of 6 degrees of climbing incline on the page 2 of the Owner's Manual and the user is not allowed to operate the device on the incline over the specified angle. The safety levels of the two devices are the same when operating the devices on the adequate inclines. They are substantially equivalent.

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Image /page/6/Picture/0 description: The image shows the word "LERADO" in a stylized font. The letters are in black and are spaced apart. The letter "A" is replaced by a black triangle. Below the word "LERADO" is the text "LERADO DESIGNS" in a smaller font.

Avenida Marciano Baotista. No.26-54b, 7 Andar. H7 Edif. Centro Com. Chong Fok Macau. China

TEL: 852-5-2475605 FAX: 852-5-2379627

The cruising ranges per charge are different; and the subject device is 12.4 miles and 22.5 miles for the predicate device. Certainly the real range depends on the practical environmental conditions, i.e., loading weight, driving surface, incline angle, and temperature. For the real life use, the two devices are substantially equivalent.

To sum up, the major differences existing between the two devices are the overall dimensions and cruising ranges. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect.

Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2014

Lerado Global Limited c/o Dr. Jen, Ke-Min Avenida Marciano Baotista, No. 26-54b, 7 Andar H7 Edif Centro Com. Chong Fok Macau CHINA

Re: K130982

Trade/Device Name: LERADO Power Wheelchair, Model DF4110 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 17, 2014 Received: January 30, 2014

Dear Dr. Ke-Min:

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. 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

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Page 2 - Dr. Jen, Ke-Min

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130982

Device Name

LERADO Power Wheelchair, model DF4110

Indications for Use (Describe)

The device is intended for medical purposes to provide mobility to persons restricted to a sitting 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

FORM FDA 3881 (9/13)

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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."

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).