Cleared Traditional

K850013 - SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR

K850013 is an FDA 510(k) clearance for SYS STIM 206(MODEL-ME 206) MUSCLE STIMU..., manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K850013 · Mettler Electronics Corp. · Physical Medicine device
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Apr 1985
Decision
96d
Days
Class 2
Risk

K850013 is an FDA 510(k) clearance for the SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 96 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.

FDA 510(k) Submission Details - K850013

510(k) Number K850013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1985
Decision Date April 08, 1985
Days to Decision 96 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
20d faster than avg
Panel avg: 116d · This submission: 96d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K850013.
ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI
K844389 · Nor-Am Patient Care Products, Inc. · May 1985
ESCOTEK-EST 204 MULTI STIM
K844390 · Nor-Am Patient Care Products, Inc. · May 1985
SINUS AC-POWERED MUSCLE STIMULATOR
K850453 · Zimmer Elektromedizin GmbH · May 1985
ELECTRONIC MUSCLE STIMULATOR
K844489 · Beverly Hills Exercise Equipment · Mar 1985
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE
K844617 · Excel Tech. , Ltd. · Mar 1985
SANYO ELECTRONIC MUSCLE STIMULATORS
K850047 · General Physiotherapy, Inc. · Mar 1985
K850013 · SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
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