← Product Code [FNL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL) · K974254 # BENEFIT B3--- SERIES (K974254) _M.C. Healthcare Products, Inc. · FNL · Dec 16, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K974254 ## Device Facts - **Applicant:** M.C. Healthcare Products, Inc. - **Product Code:** [FNL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL.md) - **Decision Date:** Dec 16, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5100 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use TO PROVIDE SUPPORT & COMFORT. TO RESIDENTS OF NURSING HOMES OR LONG TERM CARE Facilities ## Device Story Benefit B3-Series hospital bed; provides support and comfort to residents in nursing homes or long-term care facilities. Device functions as a sleeping surface. Operated by facility staff or used by residents. Output is physical support for patient rest. Benefits include patient comfort and stability during long-term care. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Hospital bed/sleeping surface. No specific materials, energy sources, or software algorithms described. ## Regulatory Identification An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. R. N. Thompson M.C. Healthcare Products, Incorporated 4658 Ontario Street Beamsville, Ontario, Canada LOR 1B4 DEC I 8 K Re : K974254 Benefit B3---Series Trade Name: Requlatory Class: II Product Code: FNL October 30, 1997 Dated: November 13, 1997 Received: Dear Mr. Thompson: 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 The general controls provisions of the Act 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 In addition, FDA may publish further announcements action. 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 {1}------------------------------------------------ Page 2 - Mr. Thompson through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 ı A latowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health a Enclosure {2}------------------------------------------------ K974254 Page ' of ' 97425.4 KASHOT 510(k) Number (if known); HOSPITAL BED. Device Name: Indications For Use: HURSING HOME + LOXE TORN CARE SLEEPING SURFACES. ." TO PROVIDE SUPPORT & COMFORT. TO RESIDENTS OF NURSING HOMES OR LONG TERM CARE Facilities : : (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF : : NEEDED) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- 11 rence of CDRH, Office of Device Evaluation (ODE) · Concu and Bach (Division Sign-Off) Division of Dental, Infection Control, and General Hor 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K974254](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K974254) **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