Cleared Abbreviated

K020478 - ELECTROMEDICARIN 900

K020478 is an FDA 510(k) clearance for ELECTROMEDICARIN 900, manufactured by Electromedicarin, S.A.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 519-day FDA review.

K020478 · Electromedicarin, S.A. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
519d
Days
Class 2
Risk

K020478 is an FDA 510(k) clearance for the ELECTROMEDICARIN 900. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Electromedicarin, S.A. (Alpharetta, US). The FDA issued a Cleared decision on July 17, 2003 after a review of 519 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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K020478

510(k) Number K020478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date July 17, 2003
Days to Decision 519 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
403d slower than avg
Panel avg: 116d · This submission: 519d
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 538
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K020478.
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
K030998 · Healthonics, Inc. · Oct 2003
RS-4I MUSCLE STIMULATOR FAMILY
K032652 · Rs Medical · Sep 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003
CEFAR REHAB 2 AND REHAB 2 PRO
K030403 · Cefar Medical AB · Jul 2003
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
K031884 · Ryan Telemedicine · Jun 2003
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
K024181 · Prizm Medical, Inc. · Jun 2003
K020478 · ELECTROMEDICARIN 900
Download PDF FDA Summary Electromedicarin, S.A.