← Product Code [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) · K023581 # COMFORT AGILE SCOOTER, LY-EW303 (K023581) _Comfort Orthopedic Co., Ltd. · INI · Dec 2, 2002 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K023581 ## Device Facts - **Applicant:** Comfort Orthopedic Co., Ltd. - **Product Code:** [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI.md) - **Decision Date:** Dec 2, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3800 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine ## Indications for Use The device is intended for medical purposes to provide mobility to persons restricted to a seated position. ## Device Story Comfort Agile Scooter (LY-EW303) is a motorized three-wheeled vehicle designed to provide mobility for individuals restricted to a seated position. Operated by the user, the device functions as a personal mobility aid. It transforms electrical power into mechanical propulsion to assist users in navigating their environment. Used in various settings, including home and community, the scooter enhances patient independence by facilitating movement. The device is controlled by the user via manual steering and throttle inputs. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Motorized three-wheeled vehicle; Class II; Product Code INI; 21 CFR 890.3800. Mechanical propulsion system. ## 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. ## 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}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a person embracing another person, with three wavy lines underneath. * ## DEC 0 2 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Comfort Orthonedic Company, LTD. Dr. Ke-Min Jen c/o Roc Chinese European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan Re: K023581 Trade/Device Name: Comfort Agile Scooter, LY-EW303 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: October 20, 2002 Received: October 24, 2002 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 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 {1}------------------------------------------------ Page 2 -- Dr. Ke-Min Jen 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. 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost for Celia M. Witten, Ph.D., MD Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1 ### 510 (K) NUMBER ( IF KNOWN ):__ TBA_ DEVICE NAME: COMFORT AGILE SCOOTER, LY-EW303 #### INDICATIONS FOR USE: The device is intended for medical purposes to provide mobility to persons restricted to a seated position. # ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OF ANOTHER PAGE ) Concurrence of CDRH, office of Device Evaluation (ODE ) Prescription Use _______________ OR Over - The - Counter - Use_ V ( Per 21 CFR 801.109 ) ( Optional Format 1-2-96 ) iriam C. Provost sion of General, Restorative d Neurological Devices Ko 23581 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K023581](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K023581) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com