Cleared Traditional

K864010 - EMPI MODEL 712

K864010 is the FDA 510(k) clearance for EMPI MODEL 712 by Empi. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K864010 · Empi · Physical Medicine device
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Dec 1986
Decision
48d
Days
Class 2
Risk

K864010 is an FDA 510(k) clearance for the EMPI MODEL 712, LOGIX(TM), NMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Empi (Minneapolis, US). The FDA issued a Cleared decision on December 2, 1986 after a review of 48 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 K864010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date December 02, 1986
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
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 K864010.
INTELECT MODEL 575
K872654 · Chattanooga Group, Inc. · Sep 1987
DYNATRON 438
K870515 · Henley Intl. · Jun 1987
MYOPAC (TM), MODEL 9600
K864625 · Medical Devices, Inc. · Dec 1986
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986
EMPI MODEL 720 NMS
K854774 · Empi · Feb 1986
EMPI MODEL 730 NMS
K854775 · Empi · Feb 1986