← Product Code [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) · K052378 # PROASIA, MODEL L3402 (K052378) _Proasia Limited · INI · Oct 7, 2005 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K052378 ## Device Facts - **Applicant:** Proasia Limited - **Product Code:** [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI.md) - **Decision Date:** Oct 7, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3800 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine ## Indications for Use Proasia L3402 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position. ## Device Story Proasia L3402 is a battery-operated, motorized three-wheeled scooter for indoor/outdoor transportation. Operated by the user via a tiller handle and thumb-operated potentiometer throttle control lever to manage forward and reverse motion. Designed for disabled or elderly individuals with limited mobility who require a seated position for transport. Device provides independent mobility; user controls speed and direction directly. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Battery-operated motorized three-wheeled vehicle. Controlled via tiller handle and thumb-operated potentiometer throttle. Class II device under 21 CFR 890.3800. ## Regulatory 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 - LANDLEX S300X ([K050792](/device/K050792.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K052378 # OCT 7 - 2005 510(k) Summary #### Device Trade name: Proasia L3402 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 LANDLEX S300X (K050792) / Besteam Technology Inc. ## Intend use of device Proasia L3402 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 L3402 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 L3402 scooter is substantially equivalent to the LANDLEX S300X (K050792) manufactured by Besteam Technology Inc.. 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 L3402 scooter is substantially equivalent to legally marketed devices currently in commercial distribution. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. OCT 7 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Jeff Chang Proasia Limited 16 F-2, No. 462, Sec. 2, Chong-De Road Beitun District, Taichung China (Taiwan) 40653 Re: K052378 Trade/Device Name: Proasia L3402 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 26, 2005 Received: August 30, 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. {2}------------------------------------------------ #### 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 (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, 25 Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 3. Device descriptive information 3.1 Statement of indication for use # Statement of Indications for Use 510(k) Number (if known): 长のSと378 Device Name: Proasia L3402 Indications for Use: The Proasia L3402 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. Over-The-Counter Use _ X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 807 Subpart C) (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 K052378 (Posted November 13, 2003) --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K052378](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K052378) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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