Cleared Traditional

K021100 - 300 PV COMPLETE ELECTROTHERAPY SYSTEM

K021100 is the FDA 510(k) clearance for 300 PV COMPLETE ELECTROTHERAPY SYSTEM by Empi. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K021100 · Empi · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
75d
Days
Class 2
Risk

K021100 is an FDA 510(k) clearance for the 300 PV COMPLETE ELECTROTHERAPY SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Empi (North Attleboro, US). The FDA issued a Cleared decision on June 18, 2002 after a review of 75 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 Empi devices

Submission Details

510(k) Number K021100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date June 18, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 114
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K021100.
VECTRA GENISYS VMS FR
K062354 · Encore Medical, L.P. · Jan 2007
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920 · Empi · Jan 2005
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941 · Rich-Mar Corp. · Oct 2003
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · Rich-Mar Corp. · Jan 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001