Cleared Abbreviated

K120922 - GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

K120922 is an FDA 510(k) clearance for GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT, manufactured by Selectivemed Components, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 317-day FDA review.

K120922 · Selectivemed Components, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
317d
Days
Class 2
Risk

K120922 is an FDA 510(k) clearance for the GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Naples, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 317 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K120922

510(k) Number K120922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date February 07, 2013
Days to Decision 317 days
Submission Type Abbreviated
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
201d slower than avg
Panel avg: 116d · This submission: 317d
Pathway characteristics
Standards-based clearance path.

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 K120922.
REVITIVE IX
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MUSCLE STIMULATION SYSTEM
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FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
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K113017 · Mettler Electronics Corp. · Jun 2012
POWERED MUSCLE STIMULATOR
K112148 · Valmed, SA · Apr 2012
K120922 · GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Download PDF FDA Summary Selectivemed Componen…