LERADO, COSCO

K050290 · Lerado Oversea Ltd. Twn Branch (Bvi) · IOR · Feb 18, 2005 · Physical Medicine

Device Facts

• Record ID: K050290
• Device Name: LERADO, COSCO
• Applicant: Lerado Oversea Ltd. Twn Branch (Bvi)
• Product Code: IOR · Physical Medicine
• Decision Date: Feb 18, 2005
• 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

Indoor/outdoor mechanical wheelchair; provides mobility for individuals restricted to seated position. Features four-wheeled base, foldable frame, and sling-style seat/back upholstery. Disassemblable for transport. Operated by user or caregiver. Output is physical mobility. Benefits include improved patient independence and ease of transport.

Clinical Evidence

Bench testing only. Device meets 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 meeting California Technical Bulletin CAL 117 flame retardant standards. Complies with ANSI/RESNA WC Vol. 1 and ISO 7176 standards.

Indications for Use

Indicated for persons restricted to a seated 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APK 1 8 2005

Lerado Oversea Ltd. TWN Branch (BVI) C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300

Re: K050290

Trade/Device Name: Lerado, Avanticare Mechanical Wheelchair, MS-8000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 4, 2005 Received: February 7,2005

Dear Dr. Ke-Min Jen:

This letter corrects our substantially equivalent letter of February 18, 2005 regarding the trade name of the device. The error on the first letter was that we had Ms-800 instead of MS-8000.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. Ke-Min Jen

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] 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/industry/support/index.html.

Sincerely yours,

Stipt Rhodes

Celia M. Witten, Ph.D., M.D. 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

The for the county of the state the state the starter of the states

COYPET 510 (K) Number ( If Known ):

Device Name: LERADO. AVANTICARE Mechanical Wheelchair, MS-8000

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)


(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,
in Neurological Devices

| (k) Number | K050290 | Page 1 of 1 |
|------------|---------|-------------|
|------------|---------|-------------|

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Image /page/3/Picture/0 description: The image shows a logo for Lerado Group. The logo consists of the word "LERADO" in bold, sans-serif font, with a triangular shape in place of the "A". Below the word "LERADO" are the words "LERADO" and "GROUP" on either side of a horizontal line. Below that is the Chinese translation of the company name.

LERADO OVERSEA LTD. TWN BRANCH(BVI No 22. Kuang Fu Road, Chia Tai Industrial Tai Pao City. ia Yi Hsien, Taiwan. ROC Fax: [phone] http:// www.lerado.com edwardI @mail.lerado.com

## 66 510(k) SUMMARY "

Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI) No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Hsien, 612, Taiwan, ROC.

Date summary prepared:

February 4,2005

Device Name:

Proprietary Name:

LERADO, AVANTICARE Mechanical Wheelchair, MS-8000 Mechanical Wheelchair Common or Usual Name: 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:

The AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Performance Testing:

AVANTICARE Mechanical Wheelchair, MS-8000 mect the applicable performance requirements as specified in ANSI/RESNA WC vol. I 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/4/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in large, bold letters, with a triangle in place of the "A". Below the word "LERADO" is the text "LERADO GROUP" in smaller letters. Below that is Chinese text.

LERADO OVERSEA LTD. TWN BRANCH(BVI) 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, ia Yi Hsien, Taiwan, ROC 886-5-2475520 Fax [phone] E-mail edwardL@mail lerado corn http // www.lerado com

## C.2 COMPARISON SUMMARY

## ( We place the related information for the predicate device in the following pages.)

From the above comparison table that the intended use and the weight limit 100kgs between the two devices are the same. Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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 same. The caster sizes are different. The predicate device's caster size is smaller and it can move more easily than the larger ones can. The weight and size of the new device is larger and the user can feel more comfortable to transport it. At last the optional accessories for the two devices are the same, thus the users have the same adversity to choose the needed accessories to accommodate their needs.

Based on the above the information and the analysis, we know that the new device and the predicate device have the same technological aspects and the same intended use, except for tiny appearance differences. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.