Cleared Traditional

K946337 - IT-727 (ALSO KNOWN AS IT-610

K946337 is an FDA 510(k) clearance for IT-727 (ALSO KNOWN AS IT-610, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K946337 · Skylark Device Co., Ltd. · Physical Medicine device
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Dec 1995
Decision
356d
Days
Class 2
Risk

K946337 is an FDA 510(k) clearance for the IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taiwan, R.O.C., TW). The FDA issued a Cleared decision on December 20, 1995 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K946337

510(k) Number K946337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1994
Decision Date December 20, 1995
Days to Decision 356 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 115d · This submission: 356d
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 31
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K946337.
DUPEL IONTOPHORESIS SYSTEM
K991991 · Empi · Sep 1999
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · Empi · Dec 1998
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · Empi · May 1997
DYNAPHOR(TM) TWO
K935868 · Maxxim Medical · Mar 1995
MICROPHOR
K913601 · Life-Tech Intl., Inc. · Jul 1994
DUPEL IONTOPHORESIS DEVICE
K915444 · Empi · Jul 1994