Cleared Traditional

K901417 - ELECTROSTIM MST

K901417 is the FDA 510(k) clearance for ELECTROSTIM MST by Promatek Industries, Ltd.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K901417 · Promatek Industries, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
155d
Days
Class 2
Risk

K901417 is an FDA 510(k) clearance for the ELECTROSTIM MST. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Promatek Industries, Ltd. (Quebec, H4p 2c9, CA). The FDA issued a Cleared decision on August 28, 1990 after a review of 155 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

Submission Details

510(k) Number K901417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date August 28, 1990
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 128
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K901417.
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K905570 · Biomedical Life Systems, Inc. · Jun 1991
MC II (TM), MODEL 7200S
K903161 · Medical Devices, Inc. · Mar 1991
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
NEUROTENS
K896620 · Henley Intl. · Apr 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989
TTS2800
K895161 · Henley Intl. · Oct 1989