Cleared Traditional

K896825 - TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR

K896825 is an FDA 510(k) clearance for TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR, manufactured by Infrasonics Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K896825 · Infrasonics Corp. · Neurology device
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Nov 1990
Decision
346d
Days
Class 2
Risk

K896825 is an FDA 510(k) clearance for the TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Infrasonics Corp. (Oakland Park, US). The FDA issued a Cleared decision on November 16, 1990 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K896825

510(k) Number K896825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date November 16, 1990
Days to Decision 346 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 148d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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 174
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K896825.
MC II (TM), MODEL 7200S
K903161 · Medical Devices, Inc. · Mar 1991
DYNATRON 200 MICROCURRENT
K903577 · Dynatronics Corp. · Mar 1991
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
MEGA-TENS DUAL CHANNEL T.E.N.S.
K903017 · Futuremed Div. of Future Impex Corp. · Oct 1990
NEUROTENS
K896620 · Henley Intl. · Apr 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989