PELVIC HOLDERS

{0} NOV-18-1996 12:38 J. T. Posey Co. 818 443 5064 P.09/11 K963437 Customer Service Toll Free: (800) 44-POSEY Tel: (818) 443-3143 Fax: (818) 443-5014 # PAYROLL DEPARTMENT NOV 19 1996 ## Posey Company 5635 Peck Road • Arcadia, California 91006-0020 U.S.A. ### SAFETY AND EFFECTIVENESS SUMMARY JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996 Phone # (818) 443-3143 FAX # (818) 443-5014 Reference Number: K963437 Trade Name: Protective Restraints Common Name: Pelvic Holders Classification Name: Protective Restraints The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, or straps and buckles. These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney. The devices used for comparative purposes are identical to the pelvic holders as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Regulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison: > "Predicate device FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products." The pelvic holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30, 1996. The limb holders have been manufactured and in commercial distribution for up to 20 years. Manufacturers and worldwide distributors of quality healthcare products since 1937