Cleared Abbreviated

K032954 - ELPHA

K032954 is an FDA 510(k) clearance for ELPHA, manufactured by Danmeter A/S. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 322-day FDA review.

K032954 · Danmeter A/S · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
322d
Days
Class 2
Risk

K032954 is an FDA 510(k) clearance for the ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Danmeter A/S (Odense C, DK). The FDA issued a Cleared decision on August 9, 2004 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Danmeter A/S devices

FDA 510(k) Submission Details - K032954

510(k) Number K032954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date August 09, 2004
Days to Decision 322 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 115d · This submission: 322d
Pathway characteristics
Standards-based clearance path.

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 157
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K032954.
VECTRA GENISYS VMS FR
K062354 · Encore Medical, L.P. · Jan 2007
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920 · Empi · Jan 2005
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · Biomedical Life Systems, Inc. · Mar 2004
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · Everyway Medical Instruments Co.,Ltd · Dec 2003