(36 days)
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Not Found
No
The summary describes a standard powered wheelchair with joystick control and does not mention any AI or ML components.
No
Explanation: The device is a powered wheelchair, which is a mobility aid rather than a device designed to diagnose, treat, or prevent a disease or condition.
No
Explanation: The device is described as a powered wheelchair, which is a mobility aid and not used for diagnosing medical conditions.
No
The device description clearly identifies the device as a "powered wheelchair," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a powered wheelchair for mobility, designed to assist individuals with movement. This is a physical assistance device, not a diagnostic tool.
- 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.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Device Type: A powered wheelchair falls under the category of medical devices used for mobility and rehabilitation, not in vitro diagnostics.
Therefore, based solely on the provided text, the Mini (P14) powered wheelchair is not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.
Product codes
ITI
Device Description
Mini (P14) Electric Powered Wheelchair
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
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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)
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Reference Device(s)
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMC-Heartway, LLC % Mr. Michael Chen President 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
DEC 2 2 2006
Re: K063474
Trade/Device Name: Mini (P14) Electric Powered Wheelchair Regulation Number: 21 CFR 888.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 14, 2006 Received: November 24, 2006
Dear Mr. Chen:
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 not 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 est on t product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Michael Chen
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
foe
N. M
Mark N. M Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo for HEARTWAY. The logo consists of a stylized floral design above the word "HEARTWAY" in a bold, sans-serif font. The floral design is white against a black square background.
Indications for Use Statement
510K number:
Device Name: Mini (P14) Electric Powered Wheelchair
Indications For Use: The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Concurrence
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K06347