Cleared Traditional

K000114 - RS-4M+MUSCLE STIMULATOR

K000114 is an FDA 510(k) clearance for RS-4M+MUSCLE STIMULATOR, manufactured by Rs Medical. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K000114 · Rs Medical · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
209d
Days
Class 2
Risk

K000114 is an FDA 510(k) clearance for the RS-4M+MUSCLE STIMULATOR. 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 August 10, 2000 after a review of 209 days - an extended review cycle.

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

FDA 510(k) Submission Details - K000114

510(k) Number K000114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2000
Decision Date August 10, 2000
Days to Decision 209 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 115d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 236
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K000114.
VECTORSURGE 5, MODEL VS-500
K002058 · Metron Medical Australia, Pty, Ltd. · May 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · Metron Medical Australia, Pty, Ltd. · Feb 2001
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · Control Solutions, Inc. · Jul 2000
HMS NEUROMUSCULAR STIMULATOR
K994062 · Home Medical Services, Inc. · Apr 2000
MS-ONE, MODEL MS-1
K994065 · Home Wellness West · Apr 2000