Cleared Traditional

K923498 - BIPHASIC UNIT

K923498 is an FDA 510(k) clearance for BIPHASIC UNIT, manufactured by Willows Health Center. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K923498 · Willows Health Center · Physical Medicine device
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Mar 1993
Decision
232d
Days
Class 2
Risk

K923498 is an FDA 510(k) clearance for the BIPHASIC UNIT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Willows Health Center (Olathe, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 232 days - an extended review cycle.

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 Willows Health Center devices

FDA 510(k) Submission Details - K923498

510(k) Number K923498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date March 04, 1993
Days to Decision 232 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
116d slower than avg
Panel avg: 116d · This submission: 232d
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 355
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K923498.
NEURO-CARE 1000
K926265 · Ems Northwest · Aug 1993
PHYACTION 787
K930670 · Verimed Holdings, Inc. · Jul 1993
PMP MUSCLE STIMULATOR
K924699 · Preferred Medical Products · Apr 1993
HIGH VOLT UNIT
K923501 · Willows Health Center · Mar 1993
LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR
K925680 · M.S.P. , Ltd. · Mar 1993
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992