Cleared Traditional

K874085 - REBUILDER(TM)

K874085 is an FDA 510(k) clearance for REBUILDER(TM), manufactured by Micromed, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K874085 · Micromed, Inc. · Neurology device
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Dec 1987
Decision
65d
Days
Class 2
Risk

K874085 is an FDA 510(k) clearance for the REBUILDER(TM). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Micromed, Inc. (Essex Junction, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 65 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 Micromed, Inc. devices

FDA 510(k) Submission Details - K874085

510(k) Number K874085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1987
Decision Date December 11, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
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 291
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K874085.
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