(38 days)
The Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position. The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people. The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility.
The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels.
This document is a 510(k) premarket notification decision letter from the FDA for a manual folding wheelchair. It does not contain information about acceptance criteria, device performance tables, or a study demonstrating that the device meets acceptance criteria as described in your request.
The provided text only contains:
- A decision letter from the FDA indicating that the Sunrise Medical Quickie QX Manual Folding Wheelchair has been found substantially equivalent to a legally marketed predicate device.
- Indications for Use Statement for the Quickie QX Manual Folding Wheelchair.
Therefore, I cannot extract the requested information points (1-9) from this document. This typically falls under a different section of a 510(k) submission, such as a "Summary of Non-Clinical Tests" or "Performance Testing" section, which is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2007
Sunrise Medical % Mr. Joseph E. Olsavsky, RAC VP-Global Quality & Regulatory 100 DeVilbiss Drive Somerset, PA 15501-2125
Re: K072153
Trade/Device Name: Quickie QX Manual Folding Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 2, 2007 Received: August 7, 2007
Dear Mr. Olsavsky:
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 - Mr. Joseph E. Olsavsky, RAC
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 (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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely von
for Polo V
Mark N. Melkerson
Dr. Dassa
9/16/05
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5.0 Indications for Use Statement
Indications for Use Statement
| 510(k) Number (if known): | Not yet assigned |
|---|---|
| Device Name: | Quickie QX Manual Folding Wheelchair |
| Indications for Use: | The Sunrise Medical Quickie QX Manual FoldingMechanical Wheelchair's intended use is to provide mobilityto persons restricted to a sitting position.The Quickie QX Manual Folding Wheelchair is a mechanicalwheelchair that is a manually operated device with wheelsthat is intended for medical purposes which provides anoptional means of mobility for physically challenged peopleThe mechanical wheelchair is indicated for physicallychallenged individuals and can provide a means of mobility |
| Prescription Use__________(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use__________X(Part 21 CFR 807 Subpart C) |
|---|---|---|
| ----------------------------------------------------------- | -------- | ---------------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
Concurrence of CDRH, Office of Device Evaluation (ODE)
| 510(k) Number__________ | 16072153 |
|---|---|
| ------------------------- | ---------- |
| Page 1 of__________ |
|---|
| --------------------- |
Page 5-1
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§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).