(22 days)
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Not Found
This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence of a medical device (Maxxim; Maxxim HD manual wheelchair). It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or studies (MRMC or standalone) because such details are not present in the provided text. The document is about regulatory clearance based on substantial equivalence, not a detailed performance study.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 1999
Mr. Scott Schweiss President Major Mobility Products, Inc. 18206 Mance Court Houston, Texas 77094
Re : K984493 Trade Name: Maxxim; Maxxim HD Requlatory Class: I Product Code: IOR Dated: December 15, 1998 Received: December 17, 1998
Dear Mr. Schweiss:
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, Druq, 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. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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. Scott Schweiss
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 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 device, 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. Whitton, Ph.D.
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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510(K) Number (if Known): م ر 98 4953
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | |
| Over-The-Counter-Use | X |
Pg. 1-10
(Division Sign-Off)
DDL Office of Dovice Evaluation (ODE)
§ 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).