(38 days)
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No
The description details a purely mechanical, manual wheelchair with no mention of software, algorithms, or any form of computational intelligence.
No.
A wheelchair is a mobility aid, not a device used to treat or alleviate a medical condition.
No
The device described is a manual wheelchair, a mobility aid for incapacitated or partially incapacitated individuals. Its function is to provide transportation, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states it is a "mechanical, manual, foldable wheelchair," which is a physical hardware device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
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. They are used outside of the body.
- Device Description: The provided description is for a mechanical, manual wheelchair. This is a device used on the human body to aid in mobility.
- Intended Use: The intended use is for providing mobility to incapacitated or partially incapacitated persons. This is a physical function, not a diagnostic test.
The description clearly indicates a device for physical support and mobility, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
A mechanical, manual, foldable wheelchair which can be used in a residential environment, managed care or public facility. This device is for incapacitated and partially incapacitated persons requiring mobility in a sitting position. The device can be operated by using downward (forward) strokes or upward (backward) strokes by the operator on the hand rim steering device attached to an made part of the wheel. To turn left or right, apply pressure on the hand rim. The device can also be powered by an attendant pushing the device with the two (left and right) rear handles. Brakes are located on either side of each wheel and can operated by the left or right hand. Expendable energy is minimal and efficient when traveling short distances.
Product codes
IOR
Device Description
A mechanical, manual, foldable wheelchair which can be used in a residential environment, managed care or public facility.
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
Residential environment, managed care or public facility for incapacitated and partially incapacitated persons. Can be operated by the user or an attendant.
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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§ 890.3850 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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Mr. Hilario E. Mata · President Runch Industrial USA, Inc. 2401 Fountainview, Suite 802 Houston, Texas 77057
Re: K980107 Runch Industrial Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: January 5, 1998 Received: January 12, 1998
Dear Mr. Mata:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Hilario E. Mata
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dr. Celia M. Witten, Ph.D.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
l Enclosure
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Indications for Use Statement
Device Name: Mechanical Wheelchair
A mechanical, manual, foldable wheelchair which can be used in a residential environment, managed care or public facility. This device is for incapacitated and partially incapacitated persons requiring mobility in a sitting position. The device can be operated by using downward (forward) strokes or upward (backward) strokes by the operator on the hand rim steering device attached to an made part of the wheel. To turn left or right, apply pressure on the hand rim. The device can also be powered by an attendant pushing the device with the two (left and right) rear handles. Brakes are located on either side of each wheel and can operated by the left or right hand. Expendable energy is minimal and efficient when traveling short distances.
Over-the-Counter Use
Sign-Off
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