Flexicair Exlipse Plus
FDA 510(k) K970295 · Hill-Rom, Inc.
510(k) numberK970295
Submission
- Device name
- Flexicair Exlipse Plus
- Applicant
- Hill-Rom, Inc.
Charleston, SC, US - Received
- January 27, 1997
- Decision date
- May 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
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| K973624 | Nurse's Aid Patient Rotation SystemIOQ · Traditional | Air Med Assist Products | 01/21/1998SE |
| K970364 | AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970363 | Hydrotec Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
| K945729 | Dynamicaire(Tm) Sleep Surface, Zoneair(Tm) Sleep SurfaceIOQ · Traditional | Hill-Rom, Inc. | 02/27/1995SE |
More from Hill-Rom, Inc.
| 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 Flexicair Exlipse Plus cleared by the FDA?
Flexicair Exlipse Plus (K970295) received a 510(k) decision of Substantially Equivalent on May 16, 1997, 109 days after the submission was received.
What is the product code of K970295?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.