EASY LIFE

{0}------------------------------------------------ K023521 NOV 1 9 2002 #### 510(k) SUMMARY ### Berkline Corporation's Model LC Series Lift Out Chairs ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Berkline Corporation One Berkline Drive Morristown, TN 37813 Phone: (423) 585-1500 Facsimile: (423) 585- 1760 Contact Person: David Popkin Senior Vice President, Legal services Date Prepared: September 24, 2002 #### Name of Device and Name/Address of Sponsor Model Easy Lift Series Lift Out Chairs Berkline Corporation One Berkline Drive Morristown, Tennessee Phone: (423) 585- 1500 Facsimile: (423) 5856- 1760 #### Common or Usual Name Lift Out Chair #### Classification Name Chair, Electric, Positioning #### Predicate Devices Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Model LC Lift Chair (K002171). #### Intended Use The intended use of the Berkline Model Easy Lift Out Chair to assist persons who have difficulty rising from a seated position to a standing position. {1}------------------------------------------------ ## Technological Characteristics and Substantial Equivalence ## A. Device Description The Berkline Model LC Series Lift Chairs are electrically powered, motor driven devices designed for use in the home or an extended care environment. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position once seated. The chairs are consist primarily of welded steel frame, an upholstered chair assembly, and motorized lift actuator. A hand held pendant type control is used activate the drive motor and raise or lower the chair to the desired position. Model numbers and physical dimensions vary with the type of aesthetic style of the chair. ### B. Substantial Equivalence The Berkline Model LC Series Lift Out Chairs are substantially equivalent to Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Corporation Model LC Series Lift Chair (K002171). Each of these products are electrically powered, motor driven, lift out chairs with the same intended function and use which is to assist elderly and/or physically challenged persons to arise from a seated position to a standing position. ## PERFORMANCE DATA The Berkline Model LC Lift Chairs have been tested to and meet: - U.L. 1647 "Standard for Motor-Operated Massage and Exercise Machines". ● - · U.L. 73 "Standard for Motor Operated Appliances" The upholstery used has been tested to and meets: - California TB 117 (Flammability) ● - UFAC Fabric Classification (Class I) . {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a human figure. NOV. 1. 9 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Berkline Corporation David Popkin Senior Vice President, Legal Services One Berkline Drive Morristown, Tennessee 37813 Re: K023521 Trade/Device Name: Easy Life Lift Chair Regulation Number: 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 1. 2002 Received: October 21, 2002 Dear Mr. Popkin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 – Mr. David Popkin . This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, for Mark A. Mellema Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known): TBD . Device Name: Berkline LLC Easy Lift Electric Positioning Chair . · Indications For Use: The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons, who have difficulty rising from a seated position to a standing position. ficulty rising from a seated position to a standing position. . : ## (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) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ for Mark A Milliken (Division Signer) (Optional Format 1-2-96) Dative a K023521