(67 days)
Not Found
No
The summary describes a standard electric wheelchair and explicitly states that AI, DNN, or ML are "Not Found".
No
The device is described as an electric wheelchair, which assists with mobility but does not provide therapy or treatment for a medical condition. Its intended use is to provide mobility, not to heal or alleviate disease, injury, or disability.
No
Explanation: The device is a power wheelchair designed for mobility, not to diagnose medical conditions.
No
The device description explicitly states it is an "Electric Wheelchair," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is an "Electric Wheelchair" intended to "provide mobility to adults." This is a device used on the body for physical support and movement, not for analyzing biological samples.
- Lack of IVD Indicators: The document lacks any mention of:
- Analyzing biological specimens.
- Diagnostic purposes related to disease or health conditions through sample analysis.
- Any components or processes associated with laboratory testing.
The IMC-Heartway HP-3 HD wheelchair is a mobility aid, not a diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.
Product codes
ITI
Device Description
IMC-Heartway rear wheel drive power base, electric wheelchair.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Juan Carlos Rivera President IMC-Heartway, LLC 6140 Mid Metro Drive, Suite 6 Fort Myers, FL 33912
APR 1 8 2003
Re: K030427
Trade/Device Name: Model HP-3 HD Electric Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: March 10, 2003 Received: March 31, 2003
Dear Mr. Rivera:
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. Juan Carlos Rivera
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark A. Millman
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: - K011745
Device Name: IMC-Heartway rear wheel drive power base, electric wheelchair.
Indications For Use: The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General, Restorative | ||
| and Neurological Devices | ||
| 510(k) Number | ||
| Prescription Use | OR | |
| The-Counter Use | Over- | |
| for Division Sign-Off | ||
| on of General, Restorative | ||
| and Neurological Devices | ||
| Number | K030427 |