HEELBO WAIST AND CHEST VEST

{0}------------------------------------------------ 980640 # Heelbo. 1134 N. Homan Ave. Chicago, IL 60651 Telex RCA 297-248 800/323-5444 312/489-7711 Fax 312/489-7744 MAY 1 1998 Heelbo. Inc. Waist and Chest Vest # 510(k) Summary # 1. Submitter's name, Address and Contact Person Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60048 Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph: Date Summary Prepared - February 17, 1998 2. Name of Device: Heelbo Waist and Chest Vest ### 3. Name of Predicate Device(s) Heelbo Pullover Poncho, K963099 Heelbo Life Jacket Poncho with Crotch Support, K963041 Posey®Waist and Chest Vest ## 4. Description of Device The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B). ## 5. Statement of Intended Use The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails. {1}------------------------------------------------ Heelbo 1134 N. Homan Ave. Chicago. IL 60651 Telex RCA 297-248 800/323-5444 312/489-7711 Fax 312/489-7744 Heelbo. Inc. Waist and Chest Vest # 6. Statement of Technological Characteristics of the Device The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices. | Characteristics | Heelbo Waist and Chest Vest<br>(proposed device) | Posey®Waist and Chest Vest<br>(predicate device) | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Intended Use | 1) help support and help prevent a<br>patient from slumping or sliding<br>forward while seated in a wheelchair<br>or geriatric chair<br>2) help prevent a patient from falling<br>out of bed or climbing over slide rails. | Same | | Materials | Polyester Cotton Blend<br>Polyester Mesh | Cotton<br>Breezeline Mesh | | Number of straps | 2 | 2 | | Where used | wheelchair, geriatric chair, bed | wheelchair, geriatric chair, bed | # 7. Biocompatibility Materials used in the construction of the proposed device are identical to materials reviewed and cleared under K963099 "Heelbo Pullover Poncho" and K963041 "Heelbo Life Jacket Poncho w/crotch Support." The suppliers of the materials used in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, over a fifteen year period using these materials, Heelbo Inc., is not aware of any adverse biological incidence. # 8. Conclusion Based upon the information presented above it is concluded that the proposed Heelbo Waist and Chest Vest is safe and effective for its intended use and is substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, composed of three overlapping profiles facing right. The profiles are rendered in black, creating a sense of depth and unity. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 #### MAY 1 1998 Heelbo, Incorporated C/O Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illionis 60048 K980640 Re : Heelbo Waist and Chest Vest Trade Name: Regulatory Class: I Product Code: FMO Dated: February 17, 1998 February 19, 1998 Received: Dear Mr. Tokarz: 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, Drug, and Cosmetic Act (Act): 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {3}------------------------------------------------ Page 2 - Mr. Tokarz the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Heelbo, Inc. Waist and Chest Vest # Statement of Intended Use 510(k) Number (if Known): Device Name: - K980640 Waist and Chest Vest Intended Use: b. The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (Per 21 CFR 801.109) OR Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________ Brenda Burke (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Page 5