Cleared Traditional

K811395 - EMPI MODEL 710

K811395 is the FDA 510(k) clearance for EMPI MODEL 710 by Empi. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K811395 · Empi · Physical Medicine device
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Aug 1981
Decision
98d
Days
Class 2
Risk

K811395 is an FDA 510(k) clearance for the EMPI MODEL 710, NMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Empi (Mchenry, US). The FDA issued a Cleared decision on August 24, 1981 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Empi devices

Submission Details

510(k) Number K811395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date August 24, 1981
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 K811395.
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168 · Mentor Corp. · Feb 1982
HIGH VOLTAGE GALVANIC STIMULATOR 550
K813456 · Chattanooga Group, Inc. · Jan 1982
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · Medtronic Vascular · Dec 1981
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · Zimmer, Inc. · Dec 1980
INTELECT
K801790 · Chattanooga Group, Inc. · Aug 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980