Cleared Traditional

K031769 - E-STRIP

K031769 is an FDA 510(k) clearance for E-STRIP, manufactured by Eemso, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K031769 · Eemso, Inc. · Physical Medicine device
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Oct 2003
Decision
127d
Days
Class 2
Risk

K031769 is an FDA 510(k) clearance for the E-STRIP. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Eemso, Inc. (Washington, US). The FDA issued a Cleared decision on October 14, 2003 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - 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 Eemso, Inc. devices

FDA 510(k) Submission Details - K031769

510(k) Number K031769 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 09, 2003
Decision Date October 14, 2003
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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 - EGJ Device, Iontophoresis, Other Uses

All 49
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K031769.
DYNATRON ION IONTOPHORESIS ELECTRODE
K060814 · Dynatronics Corp. · Jun 2006
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE
K060236 · Iomed, Inc. · Mar 2006
DYNATRON IBOX IONTOPHORESIS DEVICE
K043047 · Dynatronics Corp. · Jan 2005
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · Empi · Apr 2003
IO-DRIVE
K993081 · Selectivemed Components, Inc. · Mar 2000
IONTOPATCH
K992708 · Birch Point Medical, Inc. · Feb 2000