Cleared Traditional

K953136 - RS-4M

K953136 is the FDA 510(k) clearance for RS-4M by Rs Medical. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K953136 · Rs Medical · Physical Medicine device
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Nov 1995
Decision
147d
Days
Class 2
Risk

K953136 is an FDA 510(k) clearance for the RS-4M. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rs Medical (Vancouver, US). The FDA issued a Cleared decision on November 30, 1995 after a review of 147 days - within the typical 510(k) review window.

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 Rs Medical devices

Submission Details

510(k) Number K953136 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 06, 1995
Decision Date November 30, 1995
Days to Decision 147 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
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 K953136.
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
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