Cleared Special

K112348 - RS-4I MUSCLE STIMULATOR

K112348 is an FDA 510(k) clearance for RS-4I MUSCLE STIMULATOR, manufactured by Rs Medical. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 156-day FDA review.

K112348 · Rs Medical · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
156d
Days
Class 2
Risk

K112348 is an FDA 510(k) clearance for the RS-4I 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 January 19, 2012 after a review of 156 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112348

510(k) Number K112348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2011
Decision Date January 19, 2012
Days to Decision 156 days
Submission Type Special
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
40d slower than avg
Panel avg: 116d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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 505
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K112348.
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113010 · Famidoc Technology Co., Ltd. · Dec 2012
SYS*STIM 240
K113017 · Mettler Electronics Corp. · Jun 2012
POWERED MUSCLE STIMULATOR
K112148 · Valmed, SA · Apr 2012
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
K111279 · Zynex Medical, Inc. · Sep 2011
H-WAVE
K103738 · Electronic Waveform Laboratory, Inc. · Jun 2011
BODYFLOW P2CH
K100862 · Physiomed Elektromedizin AG · Apr 2011
K112348 · RS-4I MUSCLE STIMULATOR
Download PDF FDA Summary Rs Medical