Cleared Traditional

K844126 - SONTEC II

K844126 is the FDA 510(k) clearance for SONTEC II by Sontec, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K844126 · Sontec, Inc. · Physical Medicine device
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Jul 1985
Decision
251d
Days
Class 2
Risk

K844126 is an FDA 510(k) clearance for the SONTEC II. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Sontec, Inc. (Poway, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 251 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 Sontec, Inc. devices

Submission Details

510(k) Number K844126 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 23, 1984
Decision Date July 01, 1985
Days to Decision 251 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
136d slower than avg
Panel avg: 115d · This submission: 251d
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 153
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844126.
EMPI MODEL 720 NMS
K854774 · Empi · Feb 1986
EMPI MODEL 730 NMS
K854775 · Empi · Feb 1986
SYS*STIM 207 MODEL ME 207
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MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · Chattanooga Group, Inc. · May 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985