(118 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description is focused on basic mobility and control.
No
The device is a mobility aid (a power chair), which helps with daily living but does not treat or cure a disease or condition.
No
The device, Rumba SR (P4R), is described solely as providing mobility to adults and allowing them to self-position and operate a joystick. There is no mention of it being used to diagnose any medical condition, illness, or disease.
No
The intended use describes a device that provides mobility and allows a user to place themselves in a seated position, which strongly suggests a physical device like a wheelchair, 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 to adults and allow them to operate a joystick control. This is a physical function, not a diagnostic test performed on samples taken from the body.
- 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Rumba SR (P4R) appears to be a mobility aid, likely a powered wheelchair or scooter, based on the description of providing mobility and having a joystick control.
N/A
# Intended Use / Indications for Use
The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
# Product codes (comma separated list FDA assigned to the subject device)
ITI
# Device Description
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# 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
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 (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.
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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.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract representation of a bird, possibly an eagle, with three wing-like shapes extending from its body.
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
FEB 2 7 2007
Re: K063307
:
Trade/Device Name: Model-Rumba SR (P4R) Electric Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 19, 2007 Received: February 21, 2007
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 (sec 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. 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,
Mark N. Melkerson
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510K number: K063307
Device Name: Model - Rumba SR (P4R) Electric Powered Wheelchair
Indications For Use: The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
rescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, O Device Evaluation (ODE) (Division S Division of General, Restauri . and 1999 1998 8 11 510(k) Nun