Cleared Traditional

K954411 - GALVA-5-M

K954411 is the FDA 510(k) clearance for GALVA-5-M by Zimmer Elektromedizin GmbH. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K954411 · Zimmer Elektromedizin GmbH · Physical Medicine device
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Feb 1996
Decision
160d
Days
Class 2
Risk

K954411 is an FDA 510(k) clearance for the GALVA-5-M. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (D7910 Neu-Ulm, DE). The FDA issued a Cleared decision on February 28, 1996 after a review of 160 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 Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K954411 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 21, 1995
Decision Date February 28, 1996
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 150
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K932916 · Biomedical Life Systems, Inc. · Jan 1994