(123 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Not Found
This document is related to a 510(k) premarket notification for a motorized three-wheeled vehicle (scooter). It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for a study. This is a regulatory clearance letter, not a study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
OCT 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Comfort Orthopedic Company, LTD. Ke-Min Jen, Ph.D. c/o Roc Chinese European Industrial Research Society No. 58, Fu-Chiun Street, Hsin-Chu City, Taiwan
Re: K021910
Trade/Device Name: Comfort Dreamrider Scooter, LY-EW402 Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 4, 2002 Received: September 9, 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 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 - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Styp Rhodes
Célia 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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Page__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOWN ): _ FBA DEVICE NAME: COMFORT DREAMRIDER SCOOTER,
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 ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR | Over-The-Counter-Use | ✓ | ||
|---|---|---|---|---|---|
| ------------------ | -- | ---- | -- | ---------------------- | --- |
(Per 21 CFR 801.109)
(Optional Format 1-2-96 )
(Division Sign-Off)
Stup Rhode
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K021910 |
|---|---|
| --------------- | --------- |
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).