WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100

K060251 · Well Home Health Products Co. · IOR · Mar 8, 2006 · Physical Medicine

Device Facts

• Record ID: K060251
• Device Name: WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
• Applicant: Well Home Health Products Co.
• Product Code: IOR · Physical Medicine
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

WH Convertible Lightweight Wheelchair (WHL100) is a mechanical, foldable, indoor/outdoor wheelchair; provides mobility for individuals restricted to a seated position. Features four-wheeled base, sling-style seat/back upholstery, and convertible rear wheel configuration (12-inch or 24-inch options). Device is manually operated by the user or an assistant. Designed for transportability via disassembly and folding. Upholstery meets CAL 117 flame retardant standards. Clinical benefit includes restored mobility for patients with restricted movement.

Clinical Evidence

Bench testing only. Device meets applicable performance requirements specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Technological Characteristics

Mechanical wheelchair; foldable frame; sling-type seat/back upholstery; flame retardant fabric (CAL 117); convertible rear wheel axle (12 or 24 inch); four-wheeled base. Complies with ANSI/RESNA WC vol. 1 and ISO 7176 standards.

Indications for Use

Indicated for persons restricted to a sitting position requiring mobility assistance.

Regulatory Classification

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.

Predicate Devices

• PRO WALKER ML-300 Foldable Wheelchair (K041337)

Submission Summary (Full Text)

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January 26, 2006

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2006

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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:

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.

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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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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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 [phone]. 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 [phone] or [phone] 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

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510(k) Number K060251