(30 days)
This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.
Spectrym Small Fry Manual Folding Mobility Wheelchair
This document is a 510(k) premarket notification from the FDA, approving a "Manual Folding Mobility Wheelchair". It does not contain information about acceptance criteria or a study proving the device meets said criteria, in the way one would describe for a diagnostic or AI-powered medical device.
The document is a regulatory approval for a physical medical device (a wheelchair), not a software or diagnostic device. Therefore, the questions related to performance metrics like sensitivity, specificity, sample sizes, expert ground truth, MRMC studies, or training sets are not applicable to this type of submission.
The FDA's approval for this device is based on a determination of "substantial equivalence" to devices already marketed, not on a clinical performance study with statistical endpoints.
Therefore, I cannot provide the requested information from the provided text.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1998
Ms. Ginny S. Maloco President Freedom Designs, Inc. 2241 Madera Road Simi Valley, California 93065
Re: K983859 Manual Folding Mobility Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: October 22, 1998 October 26, 1998 Received:
Dear Ms. Maloco:
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 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 device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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, 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 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 - Ms. Ginny S. Maloco
This letter will allow you to begin marketing your device as rnscribed in your 510(k) premarket notification. The FDA ating 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 the regulation Chilication" (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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510 (k) NUMBER (IF KNOWN) : DEVICE NAME: Spectrym Small Fry Manual Folding Mobility Wheelchair INDICATIONS FOR USE:
This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) 11.00 mm and the comments of the program and the .. . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter-Use
(Optional Format 1-2-96)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K183859
§ 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).