Cleared Traditional

K861709 - A TENS (MODEL AI-86)

K861709 is an FDA 510(k) clearance for A TENS (MODEL AI-86), manufactured by American Imex. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K861709 · American Imex · Neurology device
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May 1986
Decision
11d
Days
Class 2
Risk

K861709 is an FDA 510(k) clearance for the A TENS (MODEL AI-86). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by American Imex (Irvine, US). The FDA issued a Cleared decision on May 16, 1986 after a review of 11 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 - K861709

510(k) Number K861709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1986
Decision Date May 16, 1986
Days to Decision 11 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
138d faster than avg
Panel avg: 149d · This submission: 11d
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 K861709.
EMPI MODEL 720 NMS, TENS
K861451 · Empi · Jul 1986
SKYLARK MODEL 1001 TENS DEVICE
K853898 · Peleg Intl. Co. · Jun 1986
SKYLARK GB 1000
K861214 · Peleg Intl. Co. · Jun 1986
HARIKY, MODEL GK-7
K860772 · K-Mot, Inc. · May 1986
EXER-STIM 2
K861501 · Th Charters, Inc. · May 1986
FASTENS(TM)
K854316 · Medical Devices, Inc. · Feb 1986
K861709 · A TENS (MODEL AI-86)
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