Cleared Traditional

K911066 - COMFORTRON PT (TENS)

K911066 is the FDA 510(k) clearance for COMFORTRON PT (TENS) by M. D. Supply, Inc.. It is a Class 2 Neurology device (product code GZI) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K911066 · M. D. Supply, Inc. · Neurology device
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Feb 1992
Decision
333d
Days
Class 2
Risk

K911066 is an FDA 510(k) clearance for the COMFORTRON PT (TENS). Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by M. D. Supply, Inc. (Ocala, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all M. D. Supply, Inc. devices

Submission Details

510(k) Number K911066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date February 07, 1992
Days to Decision 333 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 148d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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 Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 20
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