Cleared Traditional

K984376 - ENDOR 2000

K984376 is an FDA 510(k) clearance for ENDOR 2000, manufactured by T.C. Medical, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 548-day FDA review.

K984376 · T.C. Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
548d
Days
Class 2
Risk

K984376 is an FDA 510(k) clearance for the ENDOR 2000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by T.C. Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 548 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all T.C. Medical, Inc. devices

FDA 510(k) Submission Details - K984376

510(k) Number K984376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date June 07, 2000
Days to Decision 548 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
400d slower than avg
Panel avg: 148d · This submission: 548d
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 227
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K984376.
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd · Jan 2001
MEDISANA DIGITAL TENS
K994265 · Fuji Dynamics Limited · Jul 2000
FDTENS 2010
K994266 · Fuji Dynamics Limited · Jul 2000
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
K994387 · Woodside Biomedical, Inc. · Mar 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K991397 · Sein Electronics Co., Ltd. · Feb 2000
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
K983907 · Woodside Biomedical, Inc. · Dec 1999