Cleared Traditional

K800484 - MOD. 3127 NEUROMUSCULAR STIMULATOR

K800484 is an FDA 510(k) clearance for MOD. 3127 NEUROMUSCULAR STIMULATOR, manufactured by Medtronic Vascular. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K800484 · Medtronic Vascular · Physical Medicine device
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May 1980
Decision
59d
Days
Class 2
Risk

K800484 is an FDA 510(k) clearance for the MOD. 3127 NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 2, 1980 after a review of 59 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.

FDA 510(k) Submission Details - K800484

510(k) Number K800484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date May 02, 1980
Days to Decision 59 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 116d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K800484.
NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM.
K801577 · Inter Med Industries, Inc. · Aug 1980
INTELECT
K801790 · Chattanooga Group, Inc. · Aug 1980
PULSED GALVANIC STIMULATOR, 450-DYNAMAX
K801053 · U.S. Medical Corp. · Jun 1980
STIM-EX 201
K800486 · Th Charters, Inc. · Mar 1980
ELECTRICAL MUSCLE STIMULATOR (EMS)
K800068 · Staodynamics, Inc. · Feb 1980
PORTABLE PULSE GALVANIC STIMULATOR
K791087 · Staodynamics, Inc. · Oct 1979
K800484 · MOD. 3127 NEUROMUSCULAR STIMULATOR
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