Cleared Abbreviated

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 (K032954) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032954 · Danmeter A/S · Physical Medicine device
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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

Submission Details

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.

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

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