Cleared Traditional

K880452 - LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880452 · Lumiscope Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K880452.
actiTENS mini
K252767 · Sublimed · Jan 2026
CP Relief Wand Rx - TENS/NMES
K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · Aug 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · Oriental Inspiration Limited · Apr 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023