Cleared Traditional

K921491 - MEDI-STIM

K921491 is an FDA 510(k) clearance for MEDI-STIM, manufactured by Mid-Canada Medical. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K921491 · Mid-Canada Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
157d
Days
Class 2
Risk

K921491 is an FDA 510(k) clearance for the MEDI-STIM. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Mid-Canada Medical (Mississauga, Ontario, CA). The FDA issued a Cleared decision on September 3, 1992 after a review of 157 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 Mid-Canada Medical devices

FDA 510(k) Submission Details - K921491

510(k) Number K921491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date September 03, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 148d · This submission: 157d
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.

Regulatory Peers - LIH Interferential Current Therapy

All 45
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K921491.
INTELECT IFC2
K924666 · Chattanooga Group, Inc. · Mar 1993
DYNATRON 400
K924319 · Dynatronics Corp. · Jan 1993
ENDOMED 582
K922020 · Henley Intl. · Sep 1992
MULTI III
K921953 · Excel Tech. , Ltd. · Aug 1992
ISOTRON III
K921954 · Excel Tech. , Ltd. · Aug 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · Biomedical Life Systems, Inc. · May 1992