Cleared Traditional

K780133 - MUSCLE STIMULATOR, ELECTRICAL

K780133 is an FDA 510(k) clearance for MUSCLE STIMULATOR, manufactured by De Electronics. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K780133 · De Electronics · Physical Medicine device
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Feb 1978
Decision
9d
Days
Class 2
Risk

K780133 is an FDA 510(k) clearance for the MUSCLE STIMULATOR, ELECTRICAL. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by De Electronics (Mchenry, US). The FDA issued a Cleared decision on February 2, 1978 after a review of 9 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K780133

510(k) Number K780133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1978
Decision Date February 02, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 116d · This submission: 9d
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 K780133.
MUSCLE STIMULATOR, ELECTRONIC
K781139 · Thor Medical Instruments, Inc. · Sep 1978
STEMPLEX
K781167 · Rich-Mar Corp. · Sep 1978
GALVANATOR, MODEL 770
K781080 · Avra Corp. · Jul 1978
ELECTROTHERAPY APPARATUS E.T. 720
K770276 · Fort & Assoc. · Mar 1977
ELECTRICAL SHOCK DEVICE
K760462 · Edward V. Kaufholz, Sr. · Mar 1977
STIMULATOR, ELECTRICAL MUSCLE (#MD-4)
K760547 · R. A. Fischer Co. Corp. · Feb 1977
K780133 · MUSCLE STIMULATOR, ELECTRICAL
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