Cleared Traditional

K790847 - EGS MODEL 300

K790847 is an FDA 510(k) clearance for EGS MODEL 300, manufactured by Alfred V. Greco. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K790847 · Alfred V. Greco · Physical Medicine device
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May 1979
Decision
21d
Days
Class 2
Risk

K790847 is an FDA 510(k) clearance for the EGS MODEL 300. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Alfred V. Greco (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979 after a review of 21 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 - K790847

510(k) Number K790847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1979
Decision Date May 25, 1979
Days to Decision 21 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
95d faster than avg
Panel avg: 116d · This submission: 21d
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 543
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K790847.
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980
PORTABLE PULSE GALVANIC STIMULATOR
K791087 · Staodynamics, Inc. · Oct 1979
STIMTECH NEUROMUSCULAR STIMULATOR, C 600
K791048 · Stimulation Technology, Inc. · Jul 1979
SLENDERTONE
K790120 · Bloomex International, Inc. · May 1979
HVG-100
K790033 · Elmed, Inc. · Feb 1979
MYO-STIM
K781239 · Med General · Nov 1978
K790847 · EGS MODEL 300
Download PDF Alfred V. Greco