Cleared Traditional

K781239 - MYO-STIM

K781239 is an FDA 510(k) clearance for MYO-STIM, manufactured by Med General. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K781239 · Med General · Physical Medicine device
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Nov 1978
Decision
106d
Days
Class 2
Risk

K781239 is an FDA 510(k) clearance for the MYO-STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Med General (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 106 days - within the typical 510(k) review window.

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 Med General devices

FDA 510(k) Submission Details - K781239

510(k) Number K781239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1978
Decision Date November 03, 1978
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
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 275
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K781239.
INTELECT
K801790 · Chattanooga Group, Inc. · Aug 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980
HVG-100
K790033 · Elmed, Inc. · Feb 1979
MUSCLE STIMULATOR, ELECTRICAL
K781113 · Rich-Mar Corp. · Sep 1978
STEMPLEX
K781167 · Rich-Mar Corp. · Sep 1978
TECA MODEL SP5/T ELECTRO-THER. STIM.
K761220 · Teca, Inc. · Dec 1976