MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED

{0}------------------------------------------------ K974296 JA' - 0 1998 ## 510(k) SUMMARY JAN - 6 1998 ## Invacare Corporation's Model 720 Series Full/Semi Electric and 1120 Full Electric Beds # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558 > Contact Person: Edward A. Kroll Director, TQM and Regulatory Affairs August 1, 1997 Date Prepared: ### Name of Device and Name/Address of Sponsor Model 720 Series Full/Semi Electric Bed and 1120 Full Electric Bed Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558 ### Common or Usual Name Nursing Home Bed #### Classification Name AC Powered Adjustable Hospital Bed ### Predicate Devices The Model 720 Series Full/Semi Electric Bed and 1120 Full Electric Bed are substantially equivalent to Invacare Corporation's 5110, 5210, 5310 and 5410 Series of Home Care Beds (K925534). {1}------------------------------------------------ #### Intended Use The intended use of the Model 720 Series Full/Semi Electric and 1120 Full Electric Beds is to provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions. # Technological Characteristics and Substantial Equivalence #### A. Device Description The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user. The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze. #### B. Substantial Equivalence Products which are substantially equivalent to the 720 Series and 1120 Electric Beds are; Invacare's Model 5110, 5210, 5310 and 5410 Series Home Care Beds (K925534). Each of these products have motorized head and knee section adjustments, a pendant type push button controller and an optional motorized or manual bed height adjustment. Additional similarities are a screw type linear actuator for positioning adjustment and locking casters for maneuverability. Additionally, all provide a means for selecting and adjusting the type of surface contour and positioning which best suits the needs of the bed user. Finally, all of these devices have been granted marketing clearance by FDA under prior submissions. None of the differences between the Model 720 Series and 1120 Electric Beds and their predicate devices alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. #### Performance Data The 720 Series and 1120 Electric Beds have all been tested for and meet the requirements listed with Underwriters Laboratories (U.L.) under the 544 Standard for Safety, for Medical and Dental Equipment. They include a low voltage control system and thermal protection on the motors. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 6 1999 Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation 899 Cleveland Street Elyria, Ohio 440362-2125 K974296 Re : Model 720 Series Full/Semi Electric Bed 1120 Trade Name: Full Electric Beds Requlatory Class: II Product Code: FNL Dated: November 3, 1997 November 17, 1997 Received: Dear Mr. Kroll: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A 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 Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531 {3}------------------------------------------------ Page 2 - Mr. Kroll through 542 of the Act for devices under the Electronic Product Radiation Control 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 requlation (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 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 Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K974296 510(K) Number (if known): Unknown Device Name: Model 720 Series Full/Semi Electric and 1120 Full Electric Beds Indications for Use: To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions. ## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |---------------------------------------------------------------------|-----------------| | (Division Sign-Off) | Patricia Cuenca | | Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K974296 | Prescription Use ______ OR Over-The Counter-Use ✓ (Optional Format 1-2-96)