(18 days)
Not Found
Not Found
No
The summary describes a manual wheelchair and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The document describes a manual wheelchair, which is a mobility aid and not primarily intended for therapy or treatment of a medical condition.
No
The device, a manual wheelchair, is intended to provide mobility for physically challenged individuals. Its description clearly states its function as a mobility aid, and there is no mention of diagnostic capabilities, imaging, or analysis of medical conditions for diagnostic purposes.
No
The device description explicitly states "Manual 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 is to provide mobility for physically challenged persons. This is a therapeutic or assistive function, not a diagnostic one.
- Device Description: The device is a "Manual Wheelchair." Wheelchairs are mobility aids, not diagnostic tools.
- 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 the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
Therefore, based on the provided text, the device is a mobility aid and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Product codes
IOR
Device Description
Manual 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
all ages
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): 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.
Not Found
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.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three wavy lines that represent the staff of Asclepius, the Greek god of healing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2002
Major Mobility Products, Inc. Garry Bittner President 17323 Canton Forest Richmond, Texas 77469
Re: K022825
Trade/Device Name: Manual Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: August 12, 2002 Received: August 26, 2002
Dear Mr. Bittner:
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 - Mr. Garry Bittner
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Sincerely yours,
Mark N. Milliron
C. N. Milliron, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(K) Number (if Known):
Device Name:__________________________________________________________________________________________________________________________________________________________________ Manual Wheelchair
Indications For Use:
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Over-The-Counter-Use
. Mark A. Millerson
(Division Sign-Off)
Pg. 1-10
510(k) Number K022825