Cleared Traditional

K833928 - MYOPULSE

K833928 is the FDA 510(k) clearance for MYOPULSE by Biomedical Design Instruments. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K833928 · Biomedical Design Instruments · Physical Medicine device
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Dec 1984
Decision
396d
Days
Class 2
Risk

K833928 is an FDA 510(k) clearance for the MYOPULSE. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Biomedical Design Instruments (Walker, US). The FDA issued a Cleared decision on December 14, 1984 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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. 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 Biomedical Design Instruments devices

Submission Details

510(k) Number K833928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date December 14, 1984
Days to Decision 396 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 115d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 153
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K833928.
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · Mettler Electronics Corp. · Apr 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985
THE PROBE 100
K844466 · Rich-Mar Corp. · Feb 1985
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984
EMPI MODEL 712, LOGIX, NMS
K841382 · Empi · May 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984