(28 days)
Not Found
None
No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities that typically rely on these technologies. The device description is also missing, which would be a key place to find such information.
No
The device, a mobility power chair for adults (MPCF), is described as providing mobility. It does not treat or prevent a disease or condition, which is characteristic of a therapeutic device.
No
The device is described as providing mobility to adults, indicating a functional or assistive purpose rather than diagnosing a medical condition.
No
The summary describes a device that provides mobility to adults using a power wheelchair, implying a hardware component (the wheelchair itself) is integral to the device's function. While the summary is incomplete, the intended use strongly suggests a physical device is involved, not just 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 to adults with limited sitting ability who can operate a power wheelchair. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: While "Not Found" is listed, the intended use clearly describes a device for physical mobility.
- No Mention of Biological Samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is a core characteristic of IVDs.
- No Mention of Diagnosis: The intended use is about providing mobility, not diagnosing a disease or condition.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.
Product codes
ITI
Device Description
Not Found
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
adults
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2001
Mr. Winston Anderson Vice President Merits Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K012802
Trade/Device Name: MP3CF Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class II Product Code: ITI Dated: August 10, 2001 Received: August 21, 2001
Dear Ms. Anderson:
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. Winston Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to be finding of substantial equivalence of your device to a legally prematicated predicated with 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 11 you dealer specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0671. Additionally, for questions on the promotion and advertising of Compinative at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Nil Rt. Oglene for
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
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ mp3C Device Name:_
Indications For Use:
The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.
Signature
Winston Anderson Vice President Merits Health Products, Inc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nris for inca
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012802
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
SK.32