(113 days)
Not Found
Not Found
No
The summary describes a standard powered wheelchair with a joystick control and makes no mention of AI or ML features.
No
A powered wheelchair provides mobility for individuals and is not designed for the treatment or diagnosis of a medical condition.
No
This device is a powered wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device is described as a "powered 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 to adults using a powered wheelchair. This is a physical assistance device, not a diagnostic tool.
- Device Description: While "Not Found" is listed, the intended use clearly describes a mobility device.
- No Mention of Diagnostic Activities: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
- No Mention of IVD-Specific Terms: There are no terms related to in vitro diagnostics, such as assays, reagents, samples, or laboratory procedures.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. A powered wheelchair does not perform any of these functions.
N/A
Intended Use / Indications for Use
The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IMC Heartway, LLC % Mr. Michael Chen 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
FFB 1 3 2007
Re: K063203
Trade/Device Name: IMC-Heartway, LLC Model Rumba S (HP4) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 10, 2006 Received: January 30, 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 (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. 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
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Page 2 - Mr. Michael Chen
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.
ely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
cc: HFZ-401 DMC HFZ-404 510(k) Staff
2
Indications for Use
510(k) Number (if known) : K063203
Device Name: IMC-Heartway, LLC Model Rumba S (HP4)
Indications For Use: The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Prescription Use
AND/OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devige Evaluation (ODE)
7
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K063203