Identifiers
- 510(k) Number
- K951001 FDA 510(k)
- FDA Product Code
- IOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5170 FDA 510(k)
- Regulation Number
- 890.5170 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flexicair Exlipse is a powered flotation therapy bed device designed to provide therapeutic support. It features multiple cushions arranged in layers to create independent zones for patient comfort and pressure redistribution.
The device is intended for use with Hill-Rom Century, Centra and Advance 1000 bed frames, as well as the Stryker MPS bed frame. It has an overall height of 9.5 inches with eighteen cushions configured in three layers. The device is FDA 510(k) cleared with product code IOQ and is classified as a Class II medical device.
Frequently asked questions
What is the Flexicair Exlipse used for?
The Flexicair Exlipse is a powered flotation therapy bed designed to provide therapeutic support with multiple cushions arranged in layers to create independent zones for patient comfort and pressure redistribution.
Which bed frames is the Flexicair Exlipse compatible with?
The Flexicair Exlipse is intended for use with Hill-Rom Century, Centra and Advance 1000 bed frames, as well as the Stryker MPS bed frame.
What are the specifications of the Flexicair Exlipse?
The Flexicair Exlipse has an overall height of 9.5 inches with eighteen cushions configured in three layers. It is FDA 510(k) cleared with product code IOQ and is classified as a Class II medical device.
Is the Flexicair Exlipse reusable or single-use?
The device data does not specify whether the Flexicair Exlipse is reusable or single-use. This information would need to be obtained directly from the manufacturer or product documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FLEXICAIR EXLIPSE PLUS (K970295) — FDA 510(k) | Innolitics, Flexicair Exlipse Plus 510 (k) FDA Premarket Notification K970295 HILL ..., fda.innolitics.com, SERV.MAN-FLEXICAIR ECLIPSE | Literature | Parts | United States
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951001 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA 510(k) K951001 24 fields · synced Sep 28, 2026