(17 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device provides mobility for physically challenged individuals, which is a supportive function but not a therapeutic one in the medical sense of treating or curing a disease or condition.
No
The intended use statement focuses on providing mobility for physically challenged individuals, which is a functional purpose rather than a diagnostic one. There is no mention of detecting, monitoring, or diagnosing any medical condition.
No
The device is described as "Power Wheelchairs with Quickie/Delphi Controls," which are inherently hardware devices. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to empower physically challenged individuals by providing a means of mobility." This clearly describes a device used for physical assistance and mobility, not for testing biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a power wheelchair, which falls under the category of medical devices used for mobility and rehabilitation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls intended use is to empower physically challenged individuals by providing a means of mobility.
Product codes
ITI
Device Description
Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2006
Sunrise Medical c/o Mr. Joseph E. Olsavsky Director, Regulatory Affairs 100 DeVilbiss Drive Somerset, Pennsylvania 15501
Re: K060531
Trade/Device Name: QuickieRhythm & Groove Scries Power Wheelchairs with Ouickie/Delphi Controls Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 26, 2006 Received: March 31, 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
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CNR 1000-1050. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Herbert Larner
Mark N. Melkerson Acting 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 Rhythm & Groove Series Power Wheelchairs with |
| Quickie/Delphi Controls | |
| Indications for Use: | The Quickie Rhythm & Groove Series Power Wheelchairs |
| with Quickie/Delphi Controls intended use is to empower | |
| physically challenged individuals 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 Deyice Evaluation (ODE)
Hubert Zemer CD
(Division Sign Off)
(Division Sign-Off) Division of General. Restorative, and Neurological Devices
510(k) Number_k 06053/
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