Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5100](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5100) → FNL — Bed, Ac-Powered Adjustable Hospital # FNL · Bed, Ac-Powered Adjustable Hospital _General Hospital · 21 CFR 880.5100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL ## Overview - **Product Code:** FNL - **Device Name:** Bed, Ac-Powered Adjustable Hospital - **Regulation:** [21 CFR 880.5100](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5100) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 70) Showing 20 most recent of 70 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K202964](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K202964.md) | iBed Wireless with iBed Mobile | Stryker Corporation | Jun 18, 2021 | SESE | | [K103536](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K103536.md) | IBED WIRELESS WITH IBED AWARENESS | Stryker Corporation | Dec 16, 2010 | SESE | | [K982783](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K982783.md) | VAIL 1000 ENCLOSED BED | Vail Products, Inc. | Oct 5, 1998 | SESE | | [K974296](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K974296.md) | MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED | Invacare Corp. | Jan 6, 1998 | SESE | | [K974254](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K974254.md) | BENEFIT B3--- SERIES | M.C. Healthcare Products, Inc. | Dec 16, 1997 | SESE | | [K972115](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K972115.md) | VOLKER HOSPITAL BED, MODEL K960 | Volker Healthcare, Inc. | Aug 29, 1997 | SESE | | [K971546](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K971546.md) | SOMA 900 TRANSPORT BED | Nova Technologies, Inc. | Jul 10, 1997 | SESE | | [K963622](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K963622.md) | VAIL 2000 ENCLOSED BED | Vail Products, Inc. | May 7, 1997 | SESE | | [K963589](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K963589.md) | VAIL 3000 BED ENCLOSURE | Vail Products, Inc. | Apr 21, 1997 | SESE | | [K962942](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K962942.md) | TOTALCARE | Hill-Rom, Inc. | Feb 3, 1997 | SESE | | [K963701](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K963701.md) | SOMA SAFE ENCLOSURE | Nova Technology Corp. | Jan 24, 1997 | SESE | | [K964246](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K964246.md) | NOVABED PATIENT TRANSFER SYSTEM | Nova Technology Corp. | Jan 22, 1997 | SESE | | [K964515](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K964515.md) | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 | M.C. Healthcare Products, Inc. | Dec 31, 1996 | SESE | | [K962250](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K962250.md) | CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED | Carroll Healthcare, Inc. | Oct 21, 1996 | SESE | | [K962763](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K962763.md) | 2000 MODULAR THIRTY-NINE | Equi-Tron Mfg., Inc. | Oct 7, 1996 | SESE | | [K951514](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K951514.md) | SSC MODEL 4000 SERIES | Ssc Medical Products, Inc. | Mar 6, 1996 | SESE | | [K951735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K951735.md) | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL | Joerns Healthcare, Inc. | Aug 18, 1995 | SESE | | [K951161](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K951161.md) | MC ACCLAIM Q6000 BED | Janco Consulting Services | May 9, 1995 | SESE | | [K945042](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K945042.md) | ELITE 3 LOW AIR LOSS BED | Pegabus Egerton, Ltd. | Mar 16, 1995 | SESE | | [K946208](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL/K946208.md) | VOLKER NURSING BED MODEL 2080E & 2090E | Volker Healthcare, Inc. | Mar 14, 1995 | SESE | ## Top Applicants - Med Service, Inc. — 6 clearances - Hill-Rom, Inc. — 5 clearances - Carrom Healthcare, Inc. — 4 clearances - Kinetic Concepts, Inc. — 3 clearances - Stryker Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FNL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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