Cleared Traditional

K914231 - ELPHA 2000

K914231 is the FDA 510(k) clearance for ELPHA 2000 by Biometer Intl. A/S. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K914231 · Biometer Intl. A/S · Physical Medicine device
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May 1992
Decision
251d
Days
Class 2
Risk

K914231 is an FDA 510(k) clearance for the ELPHA 2000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Biometer Intl. A/S (Denmark, DK). The FDA issued a Cleared decision on May 28, 1992 after a review of 251 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 Biometer Intl. A/S devices

Submission Details

510(k) Number K914231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1991
Decision Date May 28, 1992
Days to Decision 251 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 115d · This submission: 251d
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 85
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K914231.
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · Chattanooga Group, Inc. · Mar 1990