The Zhenjiang Assure Mechanical Wheelchair, model:A227 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device can be disassembled for transport and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test. The maximum weight bearing capacity of the device is 250 1bs/113.5 kgs.

AI/ML Overview

This submission describes the Zhenjiang Assure Mechanical Wheelchair, model: A227, a Class 1 device intended to provide mobility to persons restricted to a sitting position. Since this is a mechanical wheelchair, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with recognized performance standards rather than typical AI/algorithm performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO/ANSI/RESNA Standards)	Reported Device Performance (Model: A227)
Static Stability (ISO7176-1:1999)	Meets applicable performance requirements.
Brake Effectiveness (ISO7176-3:2003)	Meets applicable performance requirements.
Overall Dimensions, Mass, and Maneuvering Space (ISO7176-5:2008)	Meets applicable performance requirements.
Test Dummies (ISO7176-11:1992)	Meets applicable performance requirements.
Coefficient of Friction of Test Surfaces (ISO7176-13:1989)	Meets applicable performance requirements.
Information Disclosure, Documentation, and Labelling (ISO7176-15:1996)	Meets applicable performance requirements.
Resistance to Ignition of Upholstered Parts (ISO7176-16:1997)	Meets applicable performance requirements (fabric meets flame retardant test and California Technical standard).
General Performance Requirements (ANSI/RESNA WC Vol. 1)	Meets applicable performance requirements.
Maximum Weight Bearing Capacity	250 lbs / 113.5 kgs
Ground Clearance	60 mm / 2.3"
Curb Climbing Ability	20 mm / 0.8"
Maximum Incline for Operation	Not to exceed 10 degrees (avoid too steep incline over 10 degrees).

2. Sample Size Used for the Test Set and Data Provenance:

This submission does not involve a software algorithm or AI, so there is no "test set" in the traditional sense of a dataset. The performance testing involves physical testing of the wheelchair device against established international standards. The sample size would refer to the number of physical units of the Zhenjiang Assure Mechanical Wheelchair (model: A227) that were subjected to these tests. The document does not specify the exact number of units tested.

The data provenance is from physical performance testing conducted on the device, specifically mentioned as being performed by the manufacturer, Zhenjiang Assure Medical Equipment Co., Ltd., to comply with ISO and ANSI/RESNA standards. The location of the company is Zhenjiang, China. The testing would be prospective in nature, as it's directly assessing the performance of the manufactured wheelchair model against specified criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. For a mechanical device like a wheelchair, "ground truth" is established by adherence to universally accepted engineering and safety standards (e.g., ISO, ANSI/RESNA). There are no human experts establishing a subjective ground truth for a test set in the way there would be for an AI diagnostic algorithm. Compliance is determined by objective measurements and tests. The experts involved would be engineers and technicians specialized in medical device testing and quality assurance, trained in applying these specific standards.

4. Adjudication Method for the Test Set:

Not applicable. Compliance with mechanical standards is typically determined by objective measurements and passing/failing predefined test protocols, not by expert adjudication.

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:

Not applicable. This is a mechanical wheelchair, not an AI-powered diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this mechanical device is defined by international consensus standards for wheelchair performance and safety, specifically the ISO 7176 series and ANSI/RESNA WC Vol. 1 standards. These standards prescribe specific test methods and acceptable limits for various performance parameters (e.g., static stability, brake effectiveness, ignition resistance).

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a mechanical device, there is no ground truth to be established for it.

Summary

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Zhenjiang Assure Medical Equipment Co., Ltd.

2Th Nanwei Road, Zhenjiang, China, 212000 Tel: +86-511-88896286 Fax:+86-511-88853918 Email:ceirs.jen@msa.hinet.net

APR 1 8 2012

66 510(k) SUMMARY "

K112816

Submitter's Name: Zhenjiang Assure Medical Equipment Co., Ltd. 2Th Nanwei Road, Zhenjiang City, Jiangsu, China, 212000

Date summary prepared:

September 18, 2011

Device Name:

Proprietary Name:	Zhenjiang Assure Mechanical Wheelchair, model:A227
Common or Usual Name:	Mechanical Wheelchair
Classification Name:	Mechanical Wheelchair, Class 1,21 CFR 890.3850

Indications for Use:

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Description of the device:

The maximum weight bearing capacity of the device is 250 1bs/113.5 kgs. And the following surfaces are recommended not to operate on:

Sand surface .
. Wet or icy surface
. Road maintenance hole metal cover
. Avoid going up multiple steps.
Avoid using escalators. Use the elevator.
Too steep incline over 10 degrees. .
. Ground clearance 60 mm / 2.3"
Curb climbing ability 20 mm / 0.8" .

Legally marketed device for substantial equivalence comparison:

KAIYANG Steel Wheelchair (K101999)

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Zhenjiang Assure Medical Equipment Co., Ltd. 2Th Nanwei Road, Zhenjiang, China, 212000 Tel: +86-511-88896286 Fax:+86-511-88853918 Email:ceirs.jen@msa.hinet.net

Performance Testing:

Zhenjiang Assure Mechanical Wheelchair, model:A227 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Technological Characteristics Summary:

To ensure the safety and effectiveness of the following ISO standards were completed:

ISO7176-1:1999 Wheelchairs - Part 1:Determination of Static Stability.
ISO7176-3: 2003 Wheelchairs Part 3:Determination of effectiveness of brakes. ●
ISO7176-5: 2008 Wheelchairs Part 5:Determination of overall dimensions, mass . and maneuvering space.
ISO7176-11:1992 Wheelchairs - Part 11:Test dummies.
. ISO7176-13:1989 Wheelchairs - Part 13:Determination of coefficient of friction of test surfaces.
ISO7176-15:1996 Wheelchairs - Part 15:Requirements for information disclosure, documentation and labelling.
. ISO7176-16:1997 Wheelchairs - Part 16:Resistance to ignition of upholstered parts, Requirements and test methods.

Discussion of Clinical Testing Performed:

Summary for substantial equivalence comparison:

From the above comparison table the intended use between the subject device: Zhenjiang Assure Mechanical Wheelchair, model:A227 and predicate device: KAIYANG Steel Wheelchair (K101999) are the same structure which are made by similar steel. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable Besides, back upholstery material is also the same elevating footrest. resistance-ignitability fabric and also meets the California Technical standard for flame retardant. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Zhenjiang Assure Medical Equipment Co., Ltd. % Dr. Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City Taiwan, Republic of China 30067

·APR 1 8 2012

Re: K112816

Trade/Device Name: Mechanical Wheelchair, model: A227 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 12, 2012 Received: April 12, 2012

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 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 Or ice related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Jen Ke-Min

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (K) Number ( If Known ):

Device Name: _Mechanical Wheelchair, model:A227

Indications for Use:

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Prescription Use _ (Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-The-Counter Use _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sigh-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

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510(k) Number	K112816

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).