Cleared Traditional

K760462 - ELECTRICAL SHOCK DEVICE

K760462 is an FDA 510(k) clearance for ELECTRICAL SHOCK DEVICE, manufactured by Edward V. Kaufholz, Sr.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K760462 · Edward V. Kaufholz, Sr. · Physical Medicine device
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Mar 1977
Decision
195d
Days
Class 2
Risk

K760462 is an FDA 510(k) clearance for the ELECTRICAL SHOCK DEVICE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Edward V. Kaufholz, Sr. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 195 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.

FDA 510(k) Submission Details - K760462

510(k) Number K760462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1976
Decision Date March 01, 1977
Days to Decision 195 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
79d slower than avg
Panel avg: 116d · This submission: 195d
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 537
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K760462.
GALVANATOR, MODEL 770
K781080 · Avra Corp. · Jul 1978
MUSCLE STIMULATOR, ELECTRICAL
K780133 · De Electronics · Feb 1978
ELECTROTHERAPY APPARATUS E.T. 720
K770276 · Fort & Assoc. · Mar 1977
STIMULATOR, ELECTRICAL MUSCLE (#MD-4)
K760547 · R. A. Fischer Co. Corp. · Feb 1977
TECA MODEL SP5/T ELECTRO-THER. STIM.
K761220 · Teca, Inc. · Dec 1976
MICROTYNE UNIT
K760913 · Transmed, Inc. · Nov 1976
K760462 · ELECTRICAL SHOCK DEVICE
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