Cleared Traditional

K781080 - GALVANATOR, MODEL 770

K781080 is an FDA 510(k) clearance for GALVANATOR, manufactured by Avra Corp.. 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.

K781080 · Avra Corp. · Physical Medicine device
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Jul 1978
Decision
9d
Days
Class 2
Risk

K781080 is an FDA 510(k) clearance for the GALVANATOR, MODEL 770. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Avra Corp. (Mchenry, US). The FDA issued a Cleared decision on July 7, 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 - K781080

510(k) Number K781080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1978
Decision Date July 07, 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 K781080.
MUSCLE STIMULATOR, ELECTRICAL
K781113 · Rich-Mar Corp. · Sep 1978
MUSCLE STIMULATOR, ELECTRONIC
K781139 · Thor Medical Instruments, Inc. · Sep 1978
STEMPLEX
K781167 · Rich-Mar Corp. · Sep 1978
MUSCLE STIMULATOR, ELECTRICAL
K780133 · De Electronics · Feb 1978
ELECTROTHERAPY APPARATUS E.T. 720
K770276 · Fort & Assoc. · Mar 1977
ELECTRICAL SHOCK DEVICE
K760462 · Edward V. Kaufholz, Sr. · Mar 1977
K781080 · GALVANATOR, MODEL 770
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