Cleared Traditional

K843119 - ETI TENS BELT

K843119 is an FDA 510(k) clearance for ETI TENS BELT, manufactured by Electro Therapeutic Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K843119 · Electro Therapeutic Devices, Inc. · Neurology device
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Aug 1984
Decision
9d
Days
Class 2
Risk

K843119 is an FDA 510(k) clearance for the ETI TENS BELT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Electro Therapeutic Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 9 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 - K843119

510(k) Number K843119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date August 17, 1984
Days to Decision 9 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
140d faster than avg
Panel avg: 149d · This submission: 9d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K843119.
MEA110
K843822 · Canadian Medical Products · Oct 1984
A-T TENS BELT
K843793 · A-T Surgical Mfg. Co., Inc. · Oct 1984
ELECTRO-NERVE STIMULATOR HL
K841184 · Biomedical Life Systems, Inc. · Oct 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · Mentor Corp. · Aug 1984
ECHO PULSE BURST
K842414 · Rabar, Inc. · Jul 1984
MODEL 811 VERI/TENS & PO
K840098 · Verite · Jul 1984
K843119 · ETI TENS BELT
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