Cleared Traditional

POWERSTIM ELECTRONIC MUSCLE STIMULATOR (K861399) - FDA 510(k) Clearance

K861399 · Bio-Med Systems Corp. · Physical Medicine device
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Jun 1986
Decision
63d
Days
-
Risk

K861399 is an FDA 510(k) clearance for the POWERSTIM ELECTRONIC MUSCLE STIMULATOR.

Submitted by Bio-Med Systems Corp. (Ontario, Toronto, CA). The FDA issued a Cleared decision on June 17, 1986 after a review of 63 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 Bio-Med Systems Corp. devices

Submission Details

510(k) Number K861399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date June 17, 1986
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -