(53 days)
The intended use of the HP-7 provide mobility to adults limited to thing position that have the to operates a simple han Capa
Model HP-7 Power Wheelchair
The provided text is a 510(k) Premarket Notification letter from the FDA concerning a power wheelchair (Model HP-7). This type of document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or detailed performance data for the device.
The FDA 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way typically seen for novel medical devices or AI algorithms.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from the provided text. The letter only confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to a predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the human form, and a circle of text surrounding the symbol. The text reads "U.S. Department of Health and Human Services, USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2005
Mr. John Frymark President IMC-Heartway, LLC 6140 Mid Metro Drive, Suite # 6 Fort Myers, Florida 33912
Re: K052008 Trade/Device Name: Model HP-7 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 31, 2005 Received: September 7, 2005
Dear Mr. Frymark:
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 for use stated in the encream.")76, the enactment date of the Medical Device Amendments, or 10 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). and Oosmetie Fror ( roy the the device, subject to the general controls provisions of the Act. The r va meyy atches 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 he 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 - Mr. John Frymark
This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket 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 n you a sen 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,
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Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): HP-7 Power Wheelchair Device Name: Model Indications For Use: The intended use of the HP-7 provide mobility to adults limited to thing position that have the હ to operates a simple han Capa
Image /page/2/Picture/2 description: The image shows the words "Prescription Use" followed by "(Part 21 CFR 801 Subpart D)". There is a check mark to the right of the words "Prescription Use". The text is in a simple, sans-serif font.
AND/OF.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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510(k) Number_505 2008
§ 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).