Cleared Traditional

K932610 - PCI 4000

K932610 is an FDA 510(k) clearance for PCI 4000, manufactured by Pci. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K932610 · Pci · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
83d
Days
Class 2
Risk

K932610 is an FDA 510(k) clearance for the PCI 4000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Pci (Lake Forest, US). The FDA issued a Cleared decision on August 19, 1993 after a review of 83 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.

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FDA 510(k) Submission Details - K932610

510(k) Number K932610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date August 19, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K932610.
DYNATRON 250
K944935 · Dynatronics Corp. · Jun 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833 · Rich-Mar Corp. · May 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992