Cleared Traditional

K010745 - EMS 3000

K010745 is an FDA 510(k) clearance for EMS 3000, manufactured by Dan Med, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K010745 · Dan Med, Inc. · Physical Medicine device
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Jun 2001
Decision
106d
Days
Class 2
Risk

K010745 is an FDA 510(k) clearance for the EMS 3000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Dan Med, Inc. (Denver, US). The FDA issued a Cleared decision on June 27, 2001 after a review of 106 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 Dan Med, Inc. devices

FDA 510(k) Submission Details - K010745

510(k) Number K010745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date June 27, 2001
Days to Decision 106 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
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 158
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K010745.
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
K002339 · Apex Medical Corp. · Aug 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
K002336 · Apex Medical Corp. · Jul 2001
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K000808 · Rich-Mar Corp. · Aug 2000
SYS STIM 294, MODEL ME 294
K984114 · Mettler Electronics Corp. · Feb 1999