Totalcare
FDA 510(k) K962942 · Hill-Rom, Inc.
510(k) numberK962942
Submission
- Device name
- Totalcare
- Applicant
- Hill-Rom, Inc.
Batesville, IN, US - Received
- July 29, 1996
- Decision date
- February 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5100
- Specialty
- General Hospital
Other 510(k)s with product code FNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202964 | iBed Wireless with iBed MobileFNL · Traditional | Stryker Corporation | 06/18/2021SE |
| K103536 | Ibed Wireless with Ibed AwarenessFNL · Traditional | Stryker Corporation | 12/16/2010SE |
| K982783 | Vail 1000 Enclosed BedFNL · Traditional | Vail Products, Inc. | 10/05/1998SE |
| K974296 | Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedFNL · Traditional | Invacare Corp. | 01/06/1998SE |
| K974254 | Benefit B3--- SeriesFNL · Traditional | M.C. Healthcare Products, Inc. | 12/16/1997SE |
| K972115 | Volker Hospital Bed, Model K960FNL · Traditional | Volker Healthcare, Inc. | 08/29/1997SE |
| K971546 | Soma 900 Transport BedFNL · Traditional | Nova Technologies, Inc. | 07/10/1997SE |
| K963622 | Vail 2000 Enclosed BedFNL · Traditional | Vail Products, Inc. | 05/07/1997SE |
| K963589 | Vail 3000 Bed EnclosureFNL · Traditional | Vail Products, Inc. | 04/21/1997SE |
| K963701 | Soma Safe EnclosureFNL · Traditional | Nova Technology Corp. | 01/24/1997SE |
More from Nova Technology Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260211 | Dashboard (P007000)MSX · Traditional | 08/13/2026SE |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…BZQ · Traditional | 03/04/2021SE |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…BZQ · Traditional | 05/07/2018SE |
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | 06/03/2013SE |
| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
| K973705 | Contor Table SurfaceDWJ · Traditional | 08/07/1998SE |
| K981081 | BrightstarFSY · Traditional | 04/29/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
Questions and answers
When was Totalcare cleared by the FDA?
Totalcare (K962942) received a 510(k) decision of Substantially Equivalent on February 3, 1997, 189 days after the submission was received.
What is the product code of K962942?
The FDA product code is FNL – Bed, Ac-Powered Adjustable Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5100.