Cleared Traditional

K873566 - ELECTROSTIM I.F.

K873566 is an FDA 510(k) clearance for ELECTROSTIM I.F., manufactured by Promatek Industries, Ltd.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K873566 · Promatek Industries, Ltd. · Neurology device
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Feb 1988
Decision
152d
Days
Class 2
Risk

K873566 is an FDA 510(k) clearance for the ELECTROSTIM I.F.. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Promatek Industries, Ltd. (Quebec, H4p 2c9, CA). The FDA issued a Cleared decision on February 1, 1988 after a review of 152 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Promatek Industries, Ltd. devices

FDA 510(k) Submission Details - K873566

510(k) Number K873566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date February 01, 1988
Days to Decision 152 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 148d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.