WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100 by WELL HOME HEALTH PRODUCTS CO.

The WH Convertible Lightweight Wheelchair WHL100 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. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

AI/ML Overview

This K060251 submission describes the WH Convertible Lightweight Wheelchair, Model WHL100.

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

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meet applicable performance requirements as specified in ANSI/RESNA WC vol. 1.	Device meets ANSI/RESNA WC vol. 1 standards.
Meet applicable performance requirements as specified in ISO 7176 Wheelchair Standards.	Device meets ISO 7176 Wheelchair Standards.
Weight limit of the predicate device is 100kgs/220lbs. Subject device's weight limit.	Subject device (WHL100) has a weight limit of 250lbs, exceeding the predicate device (ML-300).
Overall appearance differences are not safety aspect.	The overall appearance differences between the WHL100 and ML-300 are deemed not to be a safety aspect.
Seat heights between new device and predicate device have small difference, not leading to any safety hazard.	The small difference in seat heights between the WHL100 and ML-300 are stated not to lead to any safety hazard.
Hanger and rear axle designs are the same as the predicate device.	Hanger and rear axle designs are the same.
Caster sizes are the same as the predicate device.	Caster sizes are the same.
Weight of the new device is heavier, allowing users to feel more stable during transport.	The new device is heavier, contributing to a feeling of more stability during transport.
Upholstery fabric meets California Technical Bulletin CAL 117 standard for flame retardancy.	The upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Study Description:

The study referenced is a performance testing comparison to established wheelchair standards and a substantial equivalence comparison to a legally marketed predicate device.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the devices tested against the standards or for the comparison. It states "The WH Convertible Lightweight Wheelchair WHL100" which implies at least one unit was tested to meet the standards, and also refers to "the two devices" in the comparison.
Data Provenance: The device manufacturer (WELL HOME HEALTH PRODUCTS CO.) is located in Taichung County, Taiwan, ROC. The testing would presumably have been conducted there or by a certified laboratory on behalf of the manufacturer. The data is prospective in the sense that performance testing was conducted for this specific device to demonstrate compliance. The comparison to a predicate device is retrospective in nature, focusing on existing attributes of the predicate.

3. Number of Experts and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The performance testing against ANSI/RESNA WC vol. 1 and ISO 7176 standards would typically be performed by accredited testing laboratories with engineers and technicians experienced in wheelchair testing. The substantial equivalence comparison is a regulatory assessment.

4. Adjudication Method

The document does not describe an adjudication method in the context of expert review for a test set. This type of submission (510(k)) relies on performance testing against established standards and a direct comparison to a predicate device's characteristics, rather than subjective expert consensus on a test set.

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

No MRMC study was done. This device is a mechanical wheelchair, not an AI-assisted diagnostic or operative device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

No standalone algorithm performance was done. This device is a hardware product (mechanical wheelchair), not a software algorithm.

7. Type of Ground Truth Used

Established Industry Standards and Predicate Device Characteristics: The ground truth for performance testing is defined by recognized international and national standards (ANSI/RESNA WC vol. 1 and ISO 7176). For the substantial equivalence comparison, the ground truth is the established characteristics and performance of the legally marketed predicate device (PRO WALKER ML-300 Foldable Wheelchair, K041337).

8. Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI/ML.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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Ko625/

January 26, 2006

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2006

ell Home Health Produc

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MAR 8

66 510(k) SUMMARY "

Submitter's Name: WELL HOME HEALTH PRODUCTS CO. 1F, No.2, Alley 12, Lane 89, Yonglong 2nd St., Daili City, Taichung County, Taiwan, 412, ROC

Date summary prepared:

Device Name:

Proprietary Name:

Common or Usual Name: Classification Name:

WH Convertible Lightweight Wheelchair, WHL100 Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850

Indications for Use:

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

Description of the device:

Performance Testing:

ML-300 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:

PRO WALKER ML-300 Foldable Wheelchair ( K041337 ).

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Image /page/1/Picture/0 description: The image contains a logo for Well Home Health Products Co. The logo consists of the letters "W" and "H" in a stylized font, followed by the company name in English and Chinese. There is also a handwritten number "K060251" on the top right of the image. The text is slightly blurred, suggesting that the image may be a scan or a photograph of a document.

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Summary for substantial equivalence comparison:

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 Especially, the subject device is convertible either 24 or 12 inches of devices. the rear wheels. The overall appearance differences are not safety aspect.

The weight limit of the predicate device is 100kgs/2201bs and the subject device is 250lb. 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 are The caster sizes are same. The weight of the new device is heavier and the same. user can feel more 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 logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2006

Well Home Health Products Co. c/o Dr. Ke-Min Jen No. 58 Fu-Chiun Street Hsin-Chu City, China (Taiwan)

Re: K060251

Trade/Device Name: WH Convertible Lightweight Wheelchair, Model WHL, 100 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 13, 2006 Received: February 21, 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 cnactment 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 (11 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Dr. Jen

ff 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hulut Leen to

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

Enclosure

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Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

and the control of the country of the county of the county of

Device Name: WH Convertible Lightweight Wheelchair, WHL 100

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)

oncurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K060251

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).