REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM

{0}------------------------------------------------ # 510(K) SUMMARY 510(k) #: K111636 APR - 3 2012 Submitter: Gunnell, Inc. 8440 State Rd. PO Box 308 Millington, MI 48746 1-800-551-0055 (Phone) 989-871-4563 (Fax) Chris.chen@gunnell-inc.com (e-mail) Contact Person: Chris Chen, Ph.D. ### DEVICE IDENTIFICATION Collectively referred to as the Gunnell Rehab Series Wheelchairs Proprietary names: (GRSW) - Rehab Tough and Tilt (TNT) . - Rehab Recline and Mobility (RAM) ● - Rehab Multi-Adjustable Chair (MAC) . - Rehab Kidster (Kidster). . - Bariatric Rehab Tough and Tilt (BTNT) ● - Bariatric Rehab Recline and Mobility (BRAM) . Generic name: Manual Wheelchair Classification Name: Wheelchair, Mechanical Regulatory Class: Class I Product Code: IOR | Identification of Predicate Devices: | PDG Eclipse 400 | (#K971389) | 5/9/1997 | |--------------------------------------|------------------|------------|-----------| | | PDG Stellar | (#K990557) | 3/22/1999 | | | PDG Eclipse 600 | (#K961743) | 5/29/1996 | | | Freedom CGX | (#K080270) | 4/16/2008 | | | PDG Fuze T50 Jr. | (#K063736) | 1/17/2007 | #### INTENDED USE The purpose of The Gunnell Rehab Series Wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or {1}------------------------------------------------ extended care facility. The Kidster is the only device in the GRSW that is solely intended for pediatric users. ### DEVICE DESCRIPTION The Gunnell Rehab Series of Wheelchairs (GRSW) are manually operated, mechanical wheelchairs. The GRSW are fabricated from materials common to many other wheelchairs in the industry. In addition, the GRSW offer the same options and exhibit the same features as many other mechanical wheelchairs in the market. The entire GRSW feature a recline function. The TNT. MAC, and Kidster include a tilt in space feature, which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt feature can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access. The TNT, RAM, and Kidster also have an optional lateral tilt feature allowing for 20° lateral tilt to the right and left. The lateral tilt feature is helpful in positioning individuals with a number of different conditions. For example, this feature allows for the seat to be on a lateral angle in response to the angle or degree of scoliosis exhibited by the user thereby providing better positioning for long term usage. The TNT and the RAM are available in bariatric sizes, featuring the same options and construction as that of their respective standard models. ## SAFETY AND EFFECTIVENESS The Gunnell Rehab Series of Wheelchairs have been developed based on extensive knowledge and experience gained by providing mobility for individuals requiring assistive technology since the introduction of Gunnell Inc. in the late 1950's. This knowledge and experience has provided many satisfied individuals with durable and safe wheelchairs through the years. The GRSW are fabricated from the same materials as many wheelchairs in the industry, and offer many of the same features and options. Additionally, the GRSW successfully tested in accordance with the applicable parts of ISO 7176 (1, 3, 5, 7, 8, and 15) which includes testing for static, impact and fatigue strengths. {2}------------------------------------------------ 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ·Gunnell Incorporated % Chris Chen, Ph.D. 8440 State Road P.O. Box 308 Millington, Michigan 48746 APR - 3 2012 Re: K111636 Trade Name: Rehab Tough and Tilt (TNT) Bariatric Rehab Tough and Tilt (BTNT) Rehab Recline and Mobility (RAM) Bariatric Rehab Recline and Mobility (BRAM) Rehab Multi-Adjustable Chair (MAC) Rehab Kidster (Kidster) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 23, 2012 Received: March 27, 2012 Dear Dr. Chen: 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 10 wo sixion in 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 1 ou may, merelove, miams of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 I loase of advised that i D. Forestion that your device complies with other requirements of the Act that I Dri has made a asternment administered by other Federal agencies. You must {3}------------------------------------------------ #### Page 2 - Chris Chen. Ph.D. comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 510(k) Number (if known): K111636 Device Name: Rehab Tough and Tilt (TNT) Bariatric Rehab Tough and Tilt (BTNT) Rehab Recline and Mobility (RAM) Baritric Rehab Recline and Mobility (BRAM) Rehab Multi-Adjustable Chair (MAC) Rehab Kidster (Kidster). All of the above, collectively referred to as the Gunnell Rehab Series Wheelchairs (GRSW). Indications For Use: The intended use of all of the GRSW's is to provide mobility to individuals restricted to a sitting position. Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 801 Subpart C) な (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Wayne P. Rogers (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K111636