Cleared Traditional

K851046 - MYOCARE PLUS DUAL CHANNEL STIMULATOR

K851046 is the FDA 510(k) clearance for MYOCARE PLUS DUAL CHANNEL STIMULATOR by 3M Company. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K851046 · 3M Company · Physical Medicine device
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Jul 1985
Decision
109d
Days
Class 2
Risk

K851046 is an FDA 510(k) clearance for the MYOCARE PLUS DUAL CHANNEL STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 109 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K851046 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 14, 1985
Decision Date July 01, 1985
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
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 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K851046.
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