(106 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
COMFORT Powered Wheelchair, Traveller LY-EB103
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a "Comfort Powered Wheelchair, Traveller LY-EB103." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
The letter does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a study conducted to demonstrate performance, including sample sizes, data provenance, ground truth establishment, or expert reviews.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Comfort Orthopedic Co., Ltd. c/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, Taiwan, ROC
Re: K030356
Trade/Device Name: Comfort Powered Wheelchair, Traveller LY-EB103 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 30, 2003 Received: April 4, 2003
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), please contact the Office of Compliance at (301) 594-4659. 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,
Mule A. Mullan
Celia 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_1_of_1_
K 030356 510 (K) NUMBER ( IF KNOW ):_TBA
DEVICE NAME: COMFORT Powered Wheelchair, Traveller LY-EB103
INDICATIONS FOR USE:
. .......
The device is intended for medical purposes to provide mobility to persons restricted to a sitting 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 ) |
for Mark A. Milburn
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K030356 |
|---|---|
| --------------- | --------- |
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).