Cleared Traditional

K964423 - AXIOM INF

K964423 is an FDA 510(k) clearance for AXIOM INF, manufactured by Axiom Manufacturing. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K964423 · Axiom Manufacturing · Physical Medicine device
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Jan 1997
Decision
112d
Days
Class 2
Risk

K964423 is an FDA 510(k) clearance for the AXIOM INF. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Axiom Manufacturing (Richardson, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Axiom Manufacturing devices

FDA 510(k) Submission Details - K964423

510(k) Number K964423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date January 24, 1997
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 196
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K964423.
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · Rehabilicare, Inc. · Aug 1997
NEURO-TRAIN II (2)
K970155 · Sterne Equipment Co., Ltd. · Mar 1997
SYS STIM 226
K964028 · Mettler Electronics Corp. · Feb 1997
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
ULTRA IV
K960489 · Excel Tech. , Ltd. · Mar 1996
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995