Cleared Traditional

K800576 - CYCLOPAC CP100 TENS BANDAGE

K800576 is an FDA 510(k) clearance for CYCLOPAC CP100 TENS BANDAGE, manufactured by Cyclotechnical Medical Indust., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K800576 · Cyclotechnical Medical Indust., Inc. · Neurology device
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May 1980
Decision
69d
Days
Class 2
Risk

K800576 is an FDA 510(k) clearance for the CYCLOPAC CP100 TENS BANDAGE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cyclotechnical Medical Indust., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 69 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 - K800576

510(k) Number K800576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1980
Decision Date May 23, 1980
Days to Decision 69 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
80d faster than avg
Panel avg: 149d · This submission: 69d
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 600
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K800576.
ANASTIM II TRANSCUTANEOUS ELECTRICAL
K802227 · Biostim, Inc. · Sep 1980
ELECTRO-ACUSCOPE-70
K801459 · Nebrensky Corp. · Aug 1980
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM
K801576 · Inter Med Industries, Inc. · Aug 1980
EMPI MODEL 910S, TENS
K801112 · Empi · May 1980
TENZCARE DUAL-CHANNEL STIMULATOR
K800758 · 3M Company · Apr 1980
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
K800630 · Frye Electronics, Inc. · Apr 1980
K800576 · CYCLOPAC CP100 TENS BANDAGE
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