Cleared Traditional

K833928 - MYOPULSE

K833928 is an FDA 510(k) clearance for MYOPULSE, manufactured by Biomedical Design Instruments. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K833928

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.

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 K833928.
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
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THE PROBE 100
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INTERFERENZ 4
K842803 · Robert Bosch Corp. · Aug 1984
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K842804 · Robert Bosch Corp. · Aug 1984
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984