(51 days)
Not Found
Not Found
No
The summary describes a manual mechanical wheelchair and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, a wheelchair, provides mobility assistance but does not directly treat or cure any medical condition.
No
Explanation: The device is a manual wheelchair, described for mobility assistance and not for diagnosing any medical condition.
No
The device description explicitly states it is a "Mechanical Wheelchair," which is a 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 for mobility assistance for persons requiring it. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: It's described as a "Mechanical Wheelchair," which is a physical assistive device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing diagnostic information about a disease or condition
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.
Product codes
IOR
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
Not Found
Intended User / Care Setting
Home or outdoors, hospitals, or institution.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 1998
Mr. Eugene M. Naves President / CEO Get a Life-Give a Living Plus KiDs Project, Inc. 6561 44th Street North #3010 Pinellas Park, Florida 33781
Re : K981418 TC Series (Transport) K981419 TC Series (Tilt Recliner) · K981420 TC Series (Wide) K981421 TC Series (Recliner) K981422 TC Series Regulatory Class: I Product Code: IOR Dated: April 18, 1998 Received: April 20, 1998
Dear Mr. Naves:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
1
Page 2 - Mr. Eugene M. Naves
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 In addition, FDA may publish further announcements action. concerning your devices 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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, please. contact .. the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Collia M. Witton, Ph.D.
lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Get a Life-Give a Living Plus KiDs Project Inc .
6561 44TH Street North #3010 Pinellas Park, Florida, 33781 Telephone: 813-343-8034 Fax: 813-343-8034
501 (k) Number (if Known): _ _ ( 98) 420 _____________________________________________________________________________________________________________________________________
Device Name:_TC Series (Wide) [Mechanical Wheelchair]
Indications for Use:
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| 510(k) Number | K981420 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over- The Counter Use X |
| PAGE 7 |
(Optional Format 1-2-96)