← Product Code [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW) · K971892 # BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 (K971892) _Biomedical Horizons, Inc. · JOW · Aug 5, 1998 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K971892 ## Device Facts - **Applicant:** Biomedical Horizons, Inc. - **Product Code:** [JOW](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW.md) - **Decision Date:** Aug 5, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.5800 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Stump reduction Hand edema ## Device Story Biomedical Horizons Compression Pump, Model 651, is a pneumatic compression device used to treat edema and venous conditions. It applies intermittent pneumatic pressure to limbs to facilitate fluid movement and reduce swelling. Operated in clinical or home settings, the device functions by inflating and deflating sleeves or garments worn by the patient. Healthcare providers prescribe the device to manage chronic conditions like lymphedema or venous stasis ulcers. By promoting circulation and lymphatic drainage, the pump aids in limb volume reduction and ulcer healing, potentially improving patient comfort and mobility. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Pneumatic compression pump system; electromechanical operation; intended for limb compression therapy. Specific materials and standards not detailed in the provided text. ## Regulatory Identification A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line. Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle. ## 5 1998 AUG Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. William J. Donahue President Biomedical Horizons, Inc. P.O. Box 889 1331 Horton Road Jackson, MI 49204 Re : K971892 Biomedical Horizons Compression Pump, Model 651 Regulatory Class: II Product Code: JOW Dated: May 19, 1998 Received: May 20, 1998 Dear Mr. Donahue: 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 leqally 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). You may, therefore, market the device, subject to the qeneral 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {1}------------------------------------------------ ## Page 2 - Mr. William J. Donahue 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) 594-4648. 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" (21CFR 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/dsma/dsmamain.html." Sincerely yours, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Page 1 of 1 ## K971892 510(k) Number (il known): Compression Pump, Model 651 Device Name: Biomedical Horizons, Inc. Indications For Use: Common Indications Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Stump reduction Hand edema (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bese E. Kemper Q (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Kazi892 510(k) Number_ Prescription Use_سي_ (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K971892](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K971892) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com