(69 days)
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Not Found
No
The summary describes a manual wheelchair and explicitly states it is not electrical. There are no mentions of AI, ML, or any related technologies.
No
The device is described as a "WHEEL CHAIR(MANUAL,NOT ELECTRICAL)" used for transporting patients, which is a supportive device for mobility rather than a device for treating a disease or condition.
No
The device is described as a "WHEEL CHAIR(MANUAL,NOT ELECTRICAL)" used to "transport patient(s) and/or disable people". Its intended use is for mobility and transportation, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "WHEEL CHAIR (MANUAL, NOT ELECTRICAL)", 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 is to transport patients and disabled people. This is a physical function, not a diagnostic one.
- Device Description: It's a manual wheelchair, a mechanical device for mobility.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
In order to transport patient(s) and/or disable people This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.
Product codes
IOR
Device Description
WHEEL CHAIR(MANUAL,NOT ELECTRICAL)
Mentions image processing
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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
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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 Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Mr. Don W. Kang Manager JTS Price Corporation 2414 Second Street Fort Lee, New Jersey 07024
K992884 Re: Wheel Chair (manual, not electrical) Trade Name: Requlatory Class: I Product Code: IOR Dated: Undated August 23, 1999 Received:
Dear Mr. Kang:
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, qood 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. ਸੀ 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 requlation 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 regulations.
1
Page 2 - Mr. Don W. Kang
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 requlation (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,
Colia M. Witton, Ph.D., M.D.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K992884 510(k) Number (if known):
WHEEL CHAIR(MANUAL,NOT ELECTRICAL) Device Name:
Indications For Use:
In order to transport patient(s) and/or disable people
This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\infty$
on Sign-Off) (Division Sign-Off)
Division of General Restorative Devices 510(k) Number +
. rescription Use (Per 21 CFR 801.109)
OR
:: :
Over-The-Counter Use
r
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