Cleared Traditional

K112148 - POWERED MUSCLE STIMULATOR

K112148 is an FDA 510(k) clearance for POWERED MUSCLE STIMULATOR, manufactured by Valmed, SA. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K112148 · Valmed, SA · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
278d
Days
Class 2
Risk

K112148 is an FDA 510(k) clearance for the POWERED MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Valmed, SA (Sion, Valais, CH). The FDA issued a Cleared decision on April 30, 2012 after a review of 278 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.

FDA 510(k) Submission Details - K112148

510(k) Number K112148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date April 30, 2012
Days to Decision 278 days
Submission Type Traditional
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
162d slower than avg
Panel avg: 116d · This submission: 278d
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 494
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K112148.
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NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
K111279 · Zynex Medical, Inc. · Sep 2011
H-WAVE
K103738 · Electronic Waveform Laboratory, Inc. · Jun 2011
K112148 · POWERED MUSCLE STIMULATOR
Download PDF FDA Summary Valmed, SA