HEELBO ER WRIST RESTRAINT

{0} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 K9C3372 NOV - 7 1996 Heelbo, Inc. Heelbo ER Wrist Restraint # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 | Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860 | Date Summary Prepared - August 23, 1996 ## 2. Name of Device: Heelbo ER Wrist Restraint ## 3. Name of Predicate Device Heelbo ER Wrist Restraint ## 4. Description of Device The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The ER Wrist restraint can be used in the supine and elevated positions. The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient’s wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots. The Heelbo ER Wrist Restraint are machine washable. ## 5. Statement of Intended Use The Heelbo ER Wrist Restraint is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or elevated positions. Page 18 {1} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 Heelbo, Inc. Heelbo ER Wrist Restraint ## 6. Statement of Technological Characteristics of the Device The Heelbo ER Wrist Restraint combines a neoprene and nylon cuff limb holder with a Velcro® fastener, Quick-Release closure, Double D-Rings, and two straps. The patient’s wrist is secured into the neoprene and nylon cuff by Velcro® hook and loop straps and a Quick release closure. The attached webbed straps are then wrapped around the bed or gurney frame and are woven through a Double D-ring closure. This d-ring closure allows the caregiver to quickly and easily disconnect the restraint from the bed or gurney frame by eliminating time consuming untying of knots. The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints” dated December 1995. ## 7. Biocompatibility Assessment The subject devices are identical in component materials to the predicate devices. Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction. ## 8. Conclusion Based upon the information presented above it is concluded that the proposed Heelbo ER Wrist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 19