Cleared Traditional

K920389 - RS-2 NEUROMUSCULAR STIMULATOR

K920389 is the FDA 510(k) clearance for RS-2 NEUROMUSCULAR STIMULATOR by Rs Medical. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K920389 · Rs Medical · Physical Medicine device
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Jan 1993
Decision
364d
Days
Class 2
Risk

K920389 is an FDA 510(k) clearance for the RS-2 NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rs Medical (Washington, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 364 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 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. Elevated predicate reliance profile. 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 Rs Medical devices

Submission Details

510(k) Number K920389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date January 28, 1993
Days to Decision 364 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
249d slower than avg
Panel avg: 115d · This submission: 364d
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 108
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K920389.
ULTRA IV
K960489 · Excel Tech. , Ltd. · Mar 1996
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990