(14 days)
Not yet assigned
Not Found
No
The summary provides no indication of AI/ML technology; it describes a power wheelchair for mobility.
No
The device, a power wheelchair, is for mobility and empowerment, not for treating a disease or condition.
No
The "Intended Use / Indications for Use" states its purpose is to provide mobility for physically challenged individuals, which is not a diagnostic function.
No
The device is described as a "Power Wheelchair," which is a hardware device for mobility, not a software-only medical device.
Based on the provided information, the Quickie MWD Series II Power Wheelchair is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility for physically challenged individuals. This is a direct interaction with the patient for a physical function, not for examining specimens from the body to diagnose or monitor a condition.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Lack of IVD Characteristics: The description doesn't mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for diagnosis, monitoring, or treatment decisions based on laboratory results.
Therefore, the Quickie MWD Series II Power Wheelchair is a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quickie MWD Series II Power Wheelchair's intended use is to empower physically challenged individual by providing a means of mobility.
Product codes
ITI
Device Description
Quickie MWD Series II Power 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)
Not yet assigned
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2006
Sunrise Medical, Inc. % Joseph E. Olsavsky, RAC Director, Regulatory Affairs 7477 East Dry Creek Parkway Longmont, Colorado 80503
Re: K062701
Trade/Device Name: Quickie MWD Series II Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 7, 2006 Received: September 11, 2006
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 - 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
baye bueluno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement Section 5.0
Indications for Use Statement
| 510(k) Number (if known): | Not yet assigned |
|---|---|
| Device Name: | Quickie MWD Series II Power Wheelchair |
| Indications for Use: | The Quickie MWD Series II Power Wheelchair's |
| intended use is to empower physically challenged individual | |
| by providing 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aurbare Buchum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO4270)
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