Cleared Traditional

K882154 - HEPAX (TENS)

K882154 is an FDA 510(k) clearance for HEPAX (TENS), manufactured by Avl Scientific Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K882154 · Avl Scientific Corp. · Neurology device
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Sep 1988
Decision
130d
Days
Class 2
Risk

K882154 is an FDA 510(k) clearance for the HEPAX (TENS). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 130 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K882154

510(k) Number K882154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1988
Decision Date September 30, 1988
Days to Decision 130 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
19d faster than avg
Panel avg: 149d · This submission: 130d
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 K882154.
TX-7 (TENS) (IC-1107)
K884210 · Oms Medical Supplies, Inc. · Dec 1988
CEFAR DUAL
K883236 · Cefar Medical Products, Inc. · Nov 1988
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K884032 · Morgan Associates, Inc. · Oct 1988
TENSTAR
K874818 · Healthcheck Corp. · Sep 1988
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
K875072 · Amana Medical Group · Sep 1988
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988
K882154 · HEPAX (TENS)
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