Cleared Traditional

K844126 - SONTEC II

K844126 is an FDA 510(k) clearance for SONTEC II, manufactured by Sontec, Inc.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K844126

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.

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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K844126.
EMPI MODEL 720 NMS
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K851046 · 3M Company · Jul 1985
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K850698 · Chattanooga Group, Inc. · May 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985