Cleared Traditional

K860315 - NEUROTECH-16 PROGRAM SYSTEM CONTROLLER ...

K860315 is the FDA 510(k) clearance for NEUROTECH-16 PROGRAM SYSTEM CONTROLLER ... by Neurotech, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K860315 · Neurotech, Inc. · Physical Medicine device
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Jun 1986
Decision
140d
Days
Class 2
Risk

K860315 is an FDA 510(k) clearance for the NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Neurotech, Inc. (Washington, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 140 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 Neurotech, Inc. devices

Submission Details

510(k) Number K860315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date June 17, 1986
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K860315.
MYOPAC (TM), MODEL 9600
K864625 · Medical Devices, Inc. · Dec 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · Empi · Dec 1986
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986
RICH-MAR IF 200
K854485 · Rich-Mar Corp. · Jun 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · Mettler Electronics Corp. · Mar 1986
SYS*STIM 206 (MODEL-ME 206)
K860107 · Mettler Electronics Corp. · Mar 1986