(85 days)
The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.
Model HP-3, Power Wheelchair
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair (Model HP-3). This document does not contain the information requested for acceptance criteria and study details for a medical device's performance.
The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls, but not specific performance criteria or a study demonstrating achievement of those criteria.
Therefore, I cannot extract the requested information from this document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
AUG 3 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Juan Carlos Rivera President Transworld Mobility Distribution, LLC 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
Re: K011745
Trade/Device Name: Model HP-3 Power Wheelchair Regulation Number: 890.3825 Regulatory Class: II Product Code: ITI Dated: May 2, 2001 Received: June 5, 2001
Dear Mr. Rivera:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2 - Mr. Juan Carlos Rivera
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device of your device to a legally marketed notification. The FDA inding of substantial equal thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for m Yillo diagnostions on the promotion and advertising of your device, (301) 594-4659. Additionally, for questions on the presses on the regulation please contact the Office or Compliance an (81) ontification's (21CFR 807.97). Other general entitled, "Misoranding by relective to premarket from the Division of Small
information on your responsibilities under the Act may be obtained from the 1800) 638, 2011 on information on your responsionnies under the recent its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-boardsmapp html" Manufacturers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N Milbersen
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
{2}------------------------------------------------
Indications for Use Statement
510K number: KO11 745
Device Name: Model HP-3, Power Wheelchair
The intended use of the HP-3 is to provide mobility to adults limited to a Indications For Use: sitting position that have the capacity to operate a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Mulberon
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011745
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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).