Cleared Traditional

K923977 - AKROTECH 4000

K923977 is an FDA 510(k) clearance for AKROTECH 4000, manufactured by Lumex, Inc.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K923977 · Lumex, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
189d
Days
Class 2
Risk

K923977 is an FDA 510(k) clearance for the AKROTECH 4000. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Lumex, Inc. (Bay Shore, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 189 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.

FDA 510(k) Submission Details - K923977

510(k) Number K923977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1992
Decision Date February 12, 1993
Days to Decision 189 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
73d slower than avg
Panel avg: 116d · This submission: 189d
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 55
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K923977.
ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE
K926189 · Bio Clinic Co. · Jun 1993
MICROAIR PUP
K925694 · Gsi Medical Systems · Mar 1993
MICROAIR TURN-Q
K926456 · Gsi Development Co. · Mar 1993
RESTCUE CC
K922973 · Support Systems Intl. · Jul 1992
ORTHODERM CONVERTIBLE II
K922140 · Bio Clinic Co. · May 1992
HAZEL II
K921768 · Kinetic Concepts, Inc. · Apr 1992
K923977 · AKROTECH 4000
Download PDF Lumex, Inc.