(84 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The description focuses solely on a seating system for positional change.
No
The device is described as a "Rehab Seating System" intended for positional change in wheelchairs. While it may support rehabilitation efforts, its primary function is not to directly treat a disease or condition, but rather to provide positional support and comfort. Therapeutic devices typically imply a direct healing or mitigating effect on a medical condition.
No
The device is described as a "Rehab Seating System" intended for "positional change" for people using a powered wheelchair. This functionality suggests a therapeutic or assistive purpose, not a diagnostic one. There is no indication that it identifies, detects, measures, or monitors any medical condition or physiological state.
No
The provided text describes a "Hoveround Rehab Seating System" intended for use with a powered wheelchair. This strongly suggests a physical hardware component (the seating system itself) is the primary device, not software alone. The lack of a "Device Description" section prevents a definitive confirmation, but the name and intended use point away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "people using a powered wheelchair and requiring positional change." This describes a device used on a person for physical support and positioning, not a device used to examine specimens outside the body to diagnose or monitor a medical condition.
- 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 diagnostic or monitoring information about a patient's health status
The Hoveround Rehab Seating System appears to be a medical device, but it falls under a different category than IVDs. It's likely a mobility or rehabilitation aid.
N/A
Intended Use / Indications for Use
The Hoveround Rehab Seating System is intended for people using a powered wheelchair and requiring positional change.
Product codes
ITI
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 02 2002
Hoveround Corporation Tony DiGiovanni Director of Engineering 2151 Whitfield Industrial Way Sarasota, Florida 34243
Re: K022993
Trade/Device Name: Hoveround Rehab Seating System Regulation Number: 890.3860 Regulation Name: Powered Wheelchair (accessory) Regulatory Class: Class II Product Code: ITI Dated: November 12, 2002 Received: November 13, 2002
Dear Mr. DiGiovanni:
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
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Page 2 - Mr. Tony DiGiovanni
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 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 (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" (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.
Miriam C. Provost
(a/Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ·
510k number:
Device Name: Hoveround Rehab Seating System
Indications For Use: The Hoveround Rehab Seating System is intended for people using a powered wheelchair and requiring positional change.
(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) OR
Over-The-Counter Use
Miriam C. Provost(Optional Format 1-2-96)
Jon Sign-Off) vision of General, Restorative d Neurological Devices
K 022993