Cleared Traditional

K842888 - DUAL CHANNEL TENS, PULSAR REMOTE CONTRL

K842888 is an FDA 510(k) clearance for DUAL CHANNEL TENS, manufactured by Cryomedics, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K842888 · Cryomedics, Inc. · Neurology device
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Jan 1985
Decision
175d
Days
Class 2
Risk

K842888 is an FDA 510(k) clearance for the DUAL CHANNEL TENS, PULSAR REMOTE CONTRL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cryomedics, Inc. (Bridgeport, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryomedics, Inc. devices

FDA 510(k) Submission Details - K842888

510(k) Number K842888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date January 14, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
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 287
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K842888.
ELECTRO-NERVE STIMULATOR B4/B400
K851185 · Biomedical Life Systems, Inc. · May 1985
INTERCEPTOR, 662-01
K844279 · Intermedics, Inc. · Jan 1985
ELECTRO-NERVE STIMULATOR B5/SK700B
K844076 · Biomedical Life Systems, Inc. · Jan 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · Codman & Shurtleff, Inc. · Jan 1985
STIMTECH SD PATIENT 6089 #78-8050
K844213 · Codman & Shurtleff, Inc. · Jan 1985
ELECTRO-NERVE STIMULATOR HL
K841184 · Biomedical Life Systems, Inc. · Oct 1984