(51 days)
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Tilt Recliner) are for self-propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.
TC Series (Tilt Recliner) [Mechanical Wheelchair]
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of wheelchairs. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical devices involving algorithmic performance or diagnostic capabilities.
The letter explicitly states that the devices (manual wheelchairs) are "substantially equivalent" to predicate devices marketed before May 28, 1976. This type of clearance primarily focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or different characteristics that do not raise new questions of safety and effectiveness.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the content of this FDA letter. The letter is about regulatory clearance for mechanical wheelchairs, not about a study assessing the performance of software or an AI-powered diagnostic device against specific metrics.
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Public Health Service
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
K981418 Re : 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 April 20, 1998 Received:
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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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. ਬ 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,
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Paqe 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 requlation (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 premarket notification" (21 CFR 807.97). 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,
Celia M. Witten, Ph.D.
Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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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): C981419
Device Name: TC Series (Tilt Recliner) [Mechanical Wheelchair]
Indications for Use:
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Tilt Recliner) are for self-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) | |
|---|---|
| Division of General Restorative Devices | K981419 |
| 510(k) Number |
| Prescription Use(Per 21 CFR 801.109) | OR | Over- The Counter Use X |
|---|---|---|
| ------------------------------------------ | ---- | --------------------------------------- |
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§ 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).