Cleared Traditional

K811395 - EMPI MODEL 710, NMS

K811395 is an FDA 510(k) clearance for EMPI MODEL 710, manufactured by Empi. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K811395

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.

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 235
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