Cleared Traditional

K880452 - LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE

K880452 is an FDA 510(k) clearance for LUMISCOPE TENS MODEL 2000T OR APCC 3001..., manufactured by Lumiscope Co., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K880452 · Lumiscope Co., Inc. · Neurology device
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Mar 1988
Decision
51d
Days
Class 2
Risk

K880452 is an FDA 510(k) clearance for the LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 51 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.

View all Lumiscope Co., Inc. devices

FDA 510(k) Submission Details - K880452

510(k) Number K880452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date March 24, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 148d · This submission: 51d
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 229
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K880452.
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc. · Aug 1988
EMPI MODEL 989, TENS
K881114 · Empi · Apr 1988
ULTRAPAC II SX PLUS (TM)
K872657 · Medical Devices, Inc. · Aug 1987
MEDTENS(TM), MODEL NUMBER 7725
K871722 · Medtronic Vascular · Jul 1987
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
K871125 · Biomedical Life Systems, Inc. · Jun 1987