Nurse's Aid Patient Rotation System
FDA 510(k) K973624 · Air Med Assist Products
510(k) numberK973624
Submission
- Device name
- Nurse's Aid Patient Rotation System
- Applicant
- Air Med Assist Products
Toole, UT, US - Received
- September 23, 1997
- Decision date
- January 21, 1998
- 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
Other 510(k)s with product code IOQ
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|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | Hill-Rom | 06/03/2013SE |
| 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 |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| 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 |
Questions and answers
When was Nurse's Aid Patient Rotation System cleared by the FDA?
Nurse's Aid Patient Rotation System (K973624) received a 510(k) decision of Substantially Equivalent on January 21, 1998, 120 days after the submission was received.
What is the product code of K973624?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.