Cleared Traditional

K964208 - MD-1A GALVANIC UNIT

K964208 is an FDA 510(k) clearance for MD-1A GALVANIC UNIT, manufactured by R. A. Fischer Co. Corp.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K964208 · R. A. Fischer Co. Corp. · Physical Medicine device
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Apr 1997
Decision
208d
Days
Class 2
Risk

K964208 is an FDA 510(k) clearance for the MD-1A GALVANIC UNIT. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by R. A. Fischer Co. Corp. (Glendale, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 208 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 R. A. Fischer Co. Corp. devices

FDA 510(k) Submission Details - K964208

510(k) Number K964208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date April 30, 1997
Days to Decision 208 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
93d slower than avg
Panel avg: 115d · This submission: 208d
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 56
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K964208.
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K935868 · Maxxim Medical · Mar 1995
RH-806/GS MODEL TRANSQ(R)2
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