(80 days)
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Not Found
No
The summary describes a standard power wheelchair with a simple hand control and folding capability, with no mention of AI, ML, or related concepts.
No
The device is a power wheelchair, which is a mobility aid and not typically considered a therapeutic device designed for treating a disease or condition. Its purpose is to provide mobility.
No
The "Intended Use / Indications for Use" states that the device is to "provide mobility to adults limited to a sitting position." This describes a functional device for assistance, not one for diagnosing medical conditions.
No
The device description explicitly states "Power Wheelchair," which is a hardware device. The intended use also describes a physical chair.
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. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Power Wheelchair," which is a mobility aid.
- 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 diagnosis, monitoring, or screening of diseases or conditions.
The device's function is purely mechanical and related to providing physical support and mobility.
N/A
Intended Use / Indications for Use
The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
Product codes
ITI
Device Description
Model HP-5, Power Wheelchair
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
AUG 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Juan Carlos Rivera President Transworld Mobility Distribution, LLC 6140 Mid Metro Drive, Suite 6 Fort Myers, Florida 33912
Re: K011744
Trade/Device Name: Model HP-5, Power Wheelchair Regulation Number: 890.3825 Regulatory Class: II Product Code: ITI Dated: May 15, 2001 Received: June 5, 2001
Dear Mr. Rivera:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 stated in the enormers, to the enactment date of the Medical Device Amendments, or to devices that price to ria) = 3, a read, and the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Juan Carlos Rivera
This letter will allow you to begin marketing your device as described in your 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 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" (21CFR 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
L. Mark N. Milken
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
Indications for Use Statement
510K number:
Device Name: Model HP-5, Power Wheelchair
The intended use of the HP-5 is to provide mobility to adults limited to a Indications For Use: sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| for (Division Sign-Off) | |
| (Divisio | Division of General, Restorative |
| Divisi | and Neurological Devices |
| and Neurological Devices | |
| 510(k) Number | 510(k) Number K011744 |
| Prescription Use_ | OR Over-The-Counter Use ✓ |