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

Device Description

The WH Convertible Lightweight Wheelchair MC-281S and MC-200S is an 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. Back upholstery material is also the same resistance-ignitability fabric.

AI/ML Overview

The Medcare Mechanical Wheelchairs (MC-281S and MC-200S) are Class I medical devices intended to provide mobility to persons restricted to a seated position.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Standards)	Device Performance
ANSI/RESNA WC vol. 1 requirements	Meets applicable performance requirements
ISO 7176 Wheelchair Standards	Meets applicable performance requirements
Weight Limit: 250 lbs (Predicate)	Subject device: 100 kgs / 220 lbs

Note: The provided document states that the devices "meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." However, specific numerical or qualitative performance metrics (e.g., stability tests, fatigue tests, braking efficiency, maneuverability) from these standards are not explicitly detailed in the summary. The weight limit shows a difference from the predicate device that is addressed in the substantial equivalence comparison.

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

The provided document does not mention a test set sample size or data provenance in the context of a clinical study or performance testing involving patient data. The "Performance Testing" section refers to adherence to industry standards, not a specific clinical test with human subjects or a dataset.

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

This information is not applicable as the document does not describe a study involving a test set that requires expert-established ground truth (e.g., for diagnostic accuracy). The performance testing refers to engineering standards for mechanical function, not interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study, an effectiveness study with human readers, or an effect size for human readers improving with AI assistance. This type of study is not relevant to the described device, which is a mechanical wheelchair.

6. Standalone (Algorithm Only) Performance Study

There is no mention of a standalone (algorithm only) performance study. The device is a mechanical wheelchair and does not involve AI algorithms.

7. Type of Ground Truth Used

The ground truth for the device's performance is established by its compliance with the engineering and safety requirements outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. This is a technical validation against established industry benchmarks, not a clinical "ground truth" (e.g., pathology, outcomes data, or expert consensus) typically associated with AI/diagnostic devices.

8. Sample Size for the Training Set

This information is not applicable as the document does not describe a study involving machine learning or a training set.

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

This information is not applicable for the same reasons as point 8.

Summary

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MANUFACTURING MEDCARE

No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. FAX:886-4-7220077 TEL:886-4-7249349 E-mail:ceirs.jen@msa.hinet.net http://www.fmh.com.tw/medcare

66 510(k) SUMMARY " JUL - 5 2006

Submitter's Name: MEDCARE MANUFACTURING INC. No.351, Chungcheng Rd., Sec. 2, Changhua, 50041, Taiwan, R.O.C.

Date summary prepared: Device Name:

June 10, 2006

Proprietary Name: MEDCARE Mechanical Wheelchair, MC-281S and MC-200S Common or Usual Name: Mechanical Wheelchair Classification Name: Mechanical Wheelchair, Class I, 21 CFR 890.3850

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:

MC-281S and MC-200S are Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison: WH Convertible Lightweight Wheelchair, WHL100 ( K060251 )

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MEDCARE MANUFACTURING INC.

No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. TEL:886-4-7249349 FAX:886-4-7220077 E-mail:ceirs.jen@msa.hinet.net http://www.finh.com.tw/medcare

Summary for substantial equivalence comparison:

Caller and Roman Child States Missamming

Research Production Pro March 11 11 11 11 11 11

The intended use of the two devices is the same, and mainframes of two devices are the same foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. Especially, the subject device MC-281S has the head cushion. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

The weight limit of the subject device is 100 kgs / 220 lbs and the predicate device is 250 lbs. The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs The weight of the new device is heavier and the user can feel more are same, stable to transport it. At last the optional accessories for the two devices are same and the users have the same status to choose the needed accessories to accommodate their needs.

Thus the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is surrounded by the words "U.S. Department of Health and Human Services" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDCARE MANUFACTURING INC. % ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY Dr. Ke-Min Jen No. 58 Fu-Chiun St. JUL - 5 2006 Hsin-Chu City China (Taiwan) 30067

Re: K061694

Trade/Device Name: MEDCARE Mechanical Wheelchair, MC 281S, MC-200S Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulation Class: I Product Code: IOR Dated: June 10, 2006 Received: June 15, 2006

Dear Dr. Jen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Dr. Jen

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdr/industry/support/index.html (

Sincerely yours,

Barbaje Buclus

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

Enclosure

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MANUFACTURING INC. MEDCARE

No.351, Chungcheng Rd., Sec. 2, Changhua, 500, Taiwan, R.O.C. TEL:886-4-7249349 FAX:886-4-7220077 E-mail:ceirs.jen(@msa.hinet.net http://www.fmh.com.tw/medcare

Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: MEDCARE Mechanical Wheelchair, MC-281S, MC-200S

Indications for Use:

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

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

510(k) Numbe

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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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).