Cleared Traditional

K853750 - SYS*STIM 207 MODEL ME 207

K853750 is an FDA 510(k) clearance for SYS*STIM 207 MODEL ME 207, 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 78-day FDA review.

K853750 · Mettler Electronics Corp. · Physical Medicine device
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Nov 1985
Decision
78d
Days
Class 2
Risk

K853750 is an FDA 510(k) clearance for the SYS*STIM 207 MODEL ME 207. 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 November 26, 1985 after a review of 78 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.

FDA 510(k) Submission Details - K853750

510(k) Number K853750 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 09, 1985
Decision Date November 26, 1985
Days to Decision 78 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
38d faster than avg
Panel avg: 116d · This submission: 78d
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 K853750.
NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.
K854720 · Nemectron Medical, Inc. · Mar 1986
EMPI MODEL 720 NMS
K854774 · Empi · Feb 1986
EMPI MODEL 730 NMS
K854775 · Empi · Feb 1986
VERSA STIM 380, MUSCLE STIMULATOR
K852077 · Electro-Med Health Industries, Inc. · Aug 1985
MODEL 1000
K844727 · Verite · Jul 1985
SONTEC II
K844126 · Sontec, Inc. · Jul 1985
K853750 · SYS*STIM 207 MODEL ME 207
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