Cleared Abbreviated

K982096 - DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO

K982096 is an FDA 510(k) clearance for DERMASTIM PLUS, manufactured by Rapid Mfg. Co.. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 368-day FDA review.

K982096 · Rapid Mfg. Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
368d
Days
Class 2
Risk

K982096 is an FDA 510(k) clearance for the DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTA.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Rapid Mfg. Co. (Atlanta, US). The FDA issued a Cleared decision on June 18, 1999 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rapid Mfg. Co. devices

FDA 510(k) Submission Details - K982096

510(k) Number K982096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date June 18, 1999
Days to Decision 368 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 148d · This submission: 368d
Pathway characteristics
Standards-based clearance path.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 242
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K982096.
MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · Physiometrix, Inc. · May 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
TENS/FES/NMES ELECTRODES
K983097 · Uni-Patch, Inc. · Sep 1999
EEG ELECTRODES MODEL 445 SERIES
K982053 · Class A Ent. · Apr 1999
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K983741 · Axelgaard Mfg. Co., Ltd. · Dec 1998
SLE ELECTRODES AND ACCESSORIES
K980410 · Specialized Laboratory Equipment, Ltd. · Oct 1998