LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000

K050707 · Lerado Oversea Ltd. Twn Branch (Bvi) · IOR · Apr 18, 2005 · Physical Medicine

Device Facts

• Record ID: K050707
• Device Name: LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
• Applicant: Lerado Oversea Ltd. Twn Branch (Bvi)
• Product Code: IOR · Physical Medicine
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

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

Device Story

The AVANTICARE Transport Wheelchair, MT-3000 is a mechanical, foldable, four-wheeled indoor/outdoor wheelchair. It features a standard sling-style seat and backrest. The device is designed to provide mobility to individuals restricted to a seated position. It is intended for manual operation. The device can be disassembled for transport and is easily foldable. The upholstery fabric complies with California Technical Bulletin CAL 117 for flame retardancy.

Clinical Evidence

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

Technological Characteristics

Mechanical wheelchair; foldable frame; four-wheeled base; sling-type seat and 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

• AVANTICARE Mechanical Wheelchair, MS-8000 (K050290)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a 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.

K050707

VERSEA LTD. TWN BRANCH(BVD No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: [phone] Fax. [phone] E-mail edwardL(@mail lerado.com http:// www.lerado.com

### APR 1 8 2005

#### દ દ 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:

Device Name:

Proprietary Name:

#### LERADO .

Common or Usual Name: Classification Name:

AVANTICARE Transport Wheelchair, MT-3000 Mechanical Wheelchair Mechanica! 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 Transport Wheelchair, MT-3000 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:

AVANTICARE Transport Wheelchair, MT-3000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison:

A VANTICARE Mechanical Wheelchair, MS-8000 ( K050290 )

1/2

March 12, 2005

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Image /page/1/Picture/0 description: The image contains the text "K050707 2/2" in the upper left corner. Below this text is the logo for LERADO Group. The logo features the word "LERADO" in large, bold letters, with a triangle above the "A". Below the word "LERADO" is the text "LERADO GROUP" in smaller letters. Below this text is some Chinese characters.

LERADO OVERSEA LTD. TWN BRANCH(BVI) LENADO OVERSERIA Chia Yi Hsien, Taiwan, ROC Fax: [phone] Tel: [phone] http:// www.lerado.com [e-mail]

Summary for substantial equivalence comparison:

The intended use between the new device MT-3000 and predicate device MS-8000 Mainframes of two devices are foldable. The overall dimensions are the same. are the Same. - Triannames -- 17 Mannumer -- 12 March - 1gnitability fabric are similar. Hack upholoty in a Technical Bulletin CAL 117 standard for flame The major differences existing are the overall dimension, tire size i retardant. felardant. - The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a symbol representing health and human services.

## APR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K050707

K050707
Trade/Device Name: Lerado Avanticare Transport Wheelchair, MT-3000 Regulation Number: 21 CRF 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 12, 2005 Received: March 18, 2005

Dear Dr. Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince insubstantially equivalent (for the indications referenced above and nave uccemined we asketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manatical provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, me encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAN devices that have been reciassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval issu and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, sayest to the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the rectments reading, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (35c above) into e. Existing major regulations affecting your device. EDA it may be subject to such additional controls: Existing high one of to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 89 and can be lound in the Code of Featur Regulation in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a successful other requirements of the Act
that FDA has made a determination that your device complies with onlyg that FDA has made a delerimiation all. Jour access by other Federal agencies. You must or any Federal Statures and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, more and many of the discles desires as set CFR Part 807); labeling (21 CFR Part 800); good frances (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000); 11 CFR 1000 1050 forth in the quality Systems (QD) regalates) (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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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) This letter will allow you to begin marketing your article quivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale the nermits premarket notification. The PDA Intamg of backand. - 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
rs of the may on any 10, 2019 - Alam alone note the reculation entitled If you desire specific advice for your aconce on one one the regulation entitled, the regulation entitled, the may obtain contact the Office of Compliance at (216) 276 - 17 (215 Part 807.97). You may obtain "Misbranding by relerence to premarket nothleadon" (= : 02 stct from the Division of Small other general information on your responsion its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its to himl Manufacturers, International and Consumer Assistance aroved cdrh/industry/support/index.html.

Sincerely yours,

A. Hype Kurda
Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. 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 ): K

Device Name: LERADO, AVANTICARE Transport Wheelchair, MT-3000

Indications for Use:

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

Prescription Use AND/OR

510(k) Number_KO SO?O ?

Over-The-Counter Use

F1

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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