PROASIA, MODEL L4501

K052486 · Proasia Limited · INI · Oct 7, 2005 · Physical Medicine

Device Facts

• Record ID: K052486
• Device Name: PROASIA, MODEL L4501
• Applicant: Proasia Limited
• Product Code: INI · Physical Medicine
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The Proasia L4501 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Story

Proasia L4501 is a battery-operated, motorized three-wheeled scooter; provides indoor/outdoor transportation for disabled or elderly individuals. User operates device via tiller handle and thumb-operated potentiometer throttle control lever to engage/disengage motion in forward and reverse directions. Device intended for personal mobility; enables independent navigation for users with limited mobility.

Technological Characteristics

Battery-operated motorized three-wheeled vehicle; tiller steering; thumb-operated potentiometer throttle control; indoor/outdoor use.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor/outdoor mobility assistance.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• Bewell SC 20 (K043326)

Submission Summary (Full Text)

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OCT 7 - 2005

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K052486

2/F, Block 3, Wah Lai Industrial Centre, 10-14 Kwei Tei Street, Fo Tan, Shatin, New Territories, Hong Kong website:http://www.perfect-group.com/ TEL: + 852-26911863 FAX: + 852-26930358

# 510(k) Summary

#### Device

Trade name: Proasia L4501 scooter

Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: 89INI

Classification: Class II

### Predicate devices

## Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device

Proasia L4501 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

### Device description:

The Proasia L4501 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

### Substantial equivalence:

The Proasia L4501 scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.

There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Proasia Limited believes that the Proasia L4501 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around the symbol. The symbol is composed of three abstract human figures, each represented by a single, continuous line.

Public Health Service

OC1 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jeff Chang Proasia Limited 16F .- 2, No. 462 Sec. 2, Chong-De Road Beitun District, Taichung China (Taiwan) 40653

Re: K052486

Trade/Device Name: Proasia L4501 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: September 1, 2005 Received: September 9, 2005

Dear Mr. Chang:

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.

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#### Page 2 - Jeff Chang

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]. 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,

Mark N. Melkerson

- 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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3. Device descriptive information

3.1 Statement of indication for use

# Statement of Indications for Use

510(k) Number (if known): _(< 0 S 2486

Device Name: Proasia L4501

Indications for Use:

The Proasia L4501 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use Over-The-Counter Use _ X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

**510(k) Number** k 052486

(Posted November 13, 2003)