Cleared Traditional

K973624 - NURSE'S AID PATIENT ROTATION SYSTEM

K973624 is an FDA 510(k) clearance for NURSE'S AID PATIENT ROTATION SYSTEM, manufactured by Air Med Assist Products. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K973624 · Air Med Assist Products · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
120d
Days
Class 2
Risk

K973624 is an FDA 510(k) clearance for the NURSE'S AID PATIENT ROTATION SYSTEM. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Air Med Assist Products (Toole, US). The FDA issued a Cleared decision on January 21, 1998 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Air Med Assist Products devices

FDA 510(k) Submission Details - K973624

510(k) Number K973624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1997
Decision Date January 21, 1998
Days to Decision 120 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

All 14
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K973624.
HYDROTEC LOW AIR LOSS THERAPY BED
K970363 · Apex Metal, Inc. · Nov 1997
AIRTEC2 LOW AIR LOSS THERAPY BED
K970364 · Apex Metal, Inc. · Nov 1997
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
K970636 · Hill-Rom, Inc. · Aug 1997
SILKAIR LOW AIRLOSS THERAPY
K964873 · Hill-Rom, Inc. · Jul 1997
FLEXICAIR EXLIPSE PLUS
K970295 · Hill-Rom, Inc. · May 1997
FLEXICAIR EXLIPSE
K951001 · Hill-Rom, Inc. · Jun 1995