Cleared Traditional

PULSED GALVANIC STIMULATOR, 450-DYNAMAX (K801053) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801053 · U.S. Medical Corp. · Physical Medicine device
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Jun 1980
Decision
30d
Days
Class 2
Risk

K801053 is an FDA 510(k) clearance for the PULSED GALVANIC STIMULATOR, 450-DYNAMAX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by U.S. Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 30 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.

View all U.S. Medical Corp. devices

Submission Details

510(k) Number K801053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1980
Decision Date June 04, 1980
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 546
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