Cleared Traditional

SELECTRODE SYSTEM (K832634) - FDA 510(k) Clearance

K832634 · Bio-Stimu Trend Corp. · Neurology device
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Jan 1984
Decision
174d
Days
-
Risk

K832634 is an FDA 510(k) clearance for the SELECTRODE SYSTEM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Bio-Stimu Trend Corp. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 174 days - an extended review cycle.

This device falls under the Neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Stimu Trend Corp. devices

Submission Details

510(k) Number K832634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date January 25, 1984
Days to Decision 174 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWK Stimulator, Electro-acupuncture
Device Class -