Cleared Traditional

K992708 - IONTOPATCH

K992708 is an FDA 510(k) clearance for IONTOPATCH, manufactured by Birch Point Medical, Inc.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K992708 · Birch Point Medical, Inc. · Physical Medicine device
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Feb 2000
Decision
174d
Days
Class 2
Risk

K992708 is an FDA 510(k) clearance for the IONTOPATCH. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Birch Point Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 174 days - an extended review cycle.

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 Birch Point Medical, Inc. devices

FDA 510(k) Submission Details - K992708

510(k) Number K992708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1999
Decision Date February 01, 2000
Days to Decision 174 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 115d · This submission: 174d
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 46
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K992708.
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
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
PHORESOR II,MODEL PM900
K982668 · Iomed, Inc. · Mar 1999
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · Empi · Dec 1998