Cleared Traditional

MEDIUM FREQ. ELECTRICAL MUSCLE STIMULA (K841598) - FDA 510(k) Clearance

K841598 · Chattanooga Group, Inc. · Physical Medicine device
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May 1984
Decision
22d
Days
-
Risk

K841598 is an FDA 510(k) clearance for the MEDIUM FREQ. ELECTRICAL MUSCLE STIMULA.

Submitted by Chattanooga Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 10, 1984 after a review of 22 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 Chattanooga Group, Inc. devices

Submission Details

510(k) Number K841598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1984
Decision Date May 10, 1984
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -