Cleared Traditional

K772224 - NERVE STIMULATOR, ELEC. TRANSCUTANEOUS

K772224 is an FDA 510(k) clearance for NERVE STIMULATOR, manufactured by Stimulation Technology, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K772224 · Stimulation Technology, Inc. · Neurology device
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Dec 1977
Decision
10d
Days
Class 2
Risk

K772224 is an FDA 510(k) clearance for the NERVE STIMULATOR, ELEC. TRANSCUTANEOUS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Stimulation Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1977 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K772224

510(k) Number K772224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1977
Decision Date December 15, 1977
Days to Decision 10 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
139d faster than avg
Panel avg: 149d · This submission: 10d
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 597
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K772224.
STIMULATORS, NERVE, ELECTRICAL
K780698 · Med General · May 1978
NERVTRON-RX
K780444 · Medix Corp. · Apr 1978
NEUROMOD STIMULATOR MODEL 3723
K780186 · Medtronic Vascular · Mar 1978
IMPORTED PAIN CONTROL DEVICE
K771885 · Empi · Nov 1977
VERI/CTGS MODEL 850
K771122 · Verite Scientific, Inc. · Aug 1977
ANODYNE II-ELECTRICAL NEURO STIMULATOR
K761053 · Rich-Mar Corp. · Nov 1976
K772224 · NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
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