(38 days)
Not Found
Not Found
No
The summary describes a purely mechanical wheelchair with no mention of AI or ML components.
No
The device provides mobility assistance, which is a supportive function, but it does not treat or cure a disease or condition.
No
The provided text describes the device as a manual folding mechanical wheelchair intended for mobility, not for diagnosis. There is no mention of diagnostic functions or capabilities.
No
The device description explicitly states it is a "mechanical wheelchair" and a "manually operated device with wheels," indicating it is a physical hardware product, not software.
Based on the provided information, the Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Quickie QX is a mechanical wheelchair intended to provide mobility to individuals restricted to a sitting position. It is a physical device used for transportation and support, not for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological specimens, laboratory procedures, or diagnostic purposes.
Therefore, the Quickie QX Manual Folding Mechanical Wheelchair falls under the category of a medical device (specifically, a mobility aid), but not an IVD.
N/A
Intended Use / Indications for Use
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
Product codes
IOR
Device Description
Quickie QX Manual Folding Wheelchair
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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 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 |
| 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__________ |
|---|
| --------------------- |
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