Cleared Traditional

K926410 - ULTRATONE 8+ & 20

K926410 is an FDA 510(k) clearance for ULTRATONE 8+ & 20, manufactured by Bowater Research, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K926410 · Bowater Research, Inc. · Physical Medicine device
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Aug 1993
Decision
233d
Days
Class 2
Risk

K926410 is an FDA 510(k) clearance for the ULTRATONE 8+ & 20. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bowater Research, Inc. (Fox Lake, US). The FDA issued a Cleared decision on August 11, 1993 after a review of 233 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 Bowater Research, Inc. devices

FDA 510(k) Submission Details - K926410

510(k) Number K926410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date August 11, 1993
Days to Decision 233 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
118d slower than avg
Panel avg: 115d · This submission: 233d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K926410.
DYNATRON 250
K944935 · Dynatronics Corp. · Jun 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833 · Rich-Mar Corp. · May 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992