Cleared Traditional

K955146 - AXIOM-HVG

K955146 is an FDA 510(k) clearance for AXIOM-HVG, 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 186-day FDA review.

K955146 · Axiom Manufacturing · Physical Medicine device
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May 1996
Decision
186d
Days
Class 2
Risk

K955146 is an FDA 510(k) clearance for the AXIOM-HVG. 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 May 17, 1996 after a review of 186 days - an extended review cycle.

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 - K955146

510(k) Number K955146 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 13, 1995
Decision Date May 17, 1996
Days to Decision 186 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 115d · This submission: 186d
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 197
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