Cleared Traditional

GENERATOR (K772143) - FDA 510(k) Clearance

K772143 · Electric Field Technology Corp. · Physical Medicine device
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Jan 1978
Decision
56d
Days
-
Risk

K772143 is an FDA 510(k) clearance for the GENERATOR.

Submitted by Electric Field Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1978 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. 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.

View all Electric Field Technology Corp. devices

Submission Details

510(k) Number K772143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1977
Decision Date January 10, 1978
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -