Cleared Traditional

K970364 - AIRTEC2 LOW AIR LOSS THERAPY BED

K970364 is an FDA 510(k) clearance for AIRTEC2 LOW AIR LOSS THERAPY BED, manufactured by Apex Metal, Inc.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K970364 · Apex Metal, Inc. · Physical Medicine device
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Nov 1997
Decision
290d
Days
Class 2
Risk

K970364 is an FDA 510(k) clearance for the AIRTEC2 LOW AIR LOSS THERAPY BED. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Apex Metal, Inc. (Mt Pleasant, US). The FDA issued a Cleared decision on November 17, 1997 after a review of 290 days - an extended review cycle.

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 Apex Metal, Inc. devices

FDA 510(k) Submission Details - K970364

510(k) Number K970364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date November 17, 1997
Days to Decision 290 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 115d · This submission: 290d
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 K970364.
NURSE'S AID PATIENT ROTATION SYSTEM
K973624 · Air Med Assist Products · Jan 1998
HYDROTEC LOW AIR LOSS THERAPY BED
K970363 · 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