Cleared Traditional

K851046 - MYOCARE PLUS DUAL CHANNEL STIMULATOR

K851046 is an FDA 510(k) clearance for MYOCARE PLUS DUAL CHANNEL STIMULATOR, manufactured by 3M Company. The device is a Class 2 Physical Medicine device with 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.

View all 3M Company devices

FDA 510(k) Submission Details - K851046

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.

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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K851046.
EMPI MODEL 720 NMS
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K854775 · Empi · Feb 1986
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MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · Chattanooga Group, Inc. · May 1985
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K850013 · Mettler Electronics Corp. · Apr 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985