Cleared Traditional

K850047 - SANYO ELECTRONIC MUSCLE STIMULATORS

K850047 is the FDA 510(k) clearance for SANYO ELECTRONIC MUSCLE STIMULATORS by General Physiotherapy, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K850047 · General Physiotherapy, Inc. · Physical Medicine device
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Mar 1985
Decision
56d
Days
Class 2
Risk

K850047 is an FDA 510(k) clearance for the SANYO ELECTRONIC MUSCLE STIMULATORS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by General Physiotherapy, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Physiotherapy, Inc. devices

Submission Details

510(k) Number K850047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date March 05, 1985
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 87
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K850047.
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · Chattanooga Group, Inc. · May 1985
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · Richards Medical Co., Inc. · Apr 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984