Submission Details
| 510(k) Number | K951001 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 1995 |
| Decision Date | June 27, 1995 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
FLEXICAIR EXLIPSE
Jun 1995
Decision
116d
Days
Class 2
Risk
About This 510(k) Submission
K951001 is an FDA 510(k) clearance for the FLEXICAIR EXLIPSE, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on June 27, 1995, 116 days after receiving the submission on March 3, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.
Device Classification
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5170 |
Manufacturer
Similar Devices — IOQ Bed, Flotation Therapy, Powered
All 56
K143414 · Hill-Rom
· Mar 2015
K122473 · Hill-Rom
· Jun 2013
K973624 · Air Med Assist Products
· Jan 1998
K970363 · Apex Metal, Inc.
· Nov 1997
K970364 · Apex Metal, Inc.
· Nov 1997
K970636 · Hill-Rom, Inc.
· Aug 1997
More from Hill-Rom, Inc.
View all
K202018
· BZQ · Mar 2021
K180079
· BZQ · May 2018
K013709
· FET · Nov 2001
K973705
· DWJ · Aug 1998
K981081
· FSY · Apr 1998