VOLKER HOSPITAL BED, MODEL K960

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures representing health, services, and humanity. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 9 1997 Mr. Milton N. Beneke Jr. Official Correspondent Volker Healthcare, Incorporated C/O MDI Consultants, Incorporated -55 Northern Boulevard, Suite 410 Great Neck, New York 11021 Re : K972115 Volker Hospital Bed, Model K960 Trade Name: Regulatory Class: II Product Code: FNL Dated: June 3, 1997 Received: June 5, 1997 Dear Mr. Beneke: 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manutacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Beneke through 542 of the Act for devices under the Electronic emrough State not in the II provisions, or other Federal laws or requlations. 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 ene regulation Cherclea, "Meblanding "I "Sther 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, Timothy A. Ulatowski Timo Directpr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): Device Name: Volker Hospital Bed, Model K-960 This device is intended for medical purposes Indications For Use: in hospitals or nursing homes for use by the staff or in hospicals of nursing nomes rod surface contour of the patients to adjast one norgin and ors. The device includes bed using built-in crecorre motis and wheels for movement moveable and fatenably in this bed is not of the bed to dirrerent rocations. In a 12 years of age. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AND THERE PAGE IF HEEDED) cacurence of CDRH, Office of Device Evaluation (ODE) Patricio Casanate Prescription Use (Per 21 CFR 801.109) OR Over-The-Courter Use (Optional Forced 1-2-96)