Cleared Traditional

K853416 - MES-TENS(TENS)

K853416 is the FDA 510(k) clearance for MES-TENS(TENS) by Oriental Medical Supplies, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K853416 · Oriental Medical Supplies, Inc. · Neurology device
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Nov 1985
Decision
85d
Days
Class 2
Risk

K853416 is an FDA 510(k) clearance for the MES-TENS(TENS). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Oriental Medical Supplies, Inc. (Braintree, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 85 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 Oriental Medical Supplies, Inc. devices

Submission Details

510(k) Number K853416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1985
Decision Date November 07, 1985
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 129
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K853416.
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K851735 · Mettler Electronics Corp. · Nov 1985
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K851063 · Intermedics, Inc. · Jun 1985
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K851191 · Biomedical Life Systems, Inc. · May 1985
ELECTRO-NERVE STIMULATOR B4/B400
K851185 · Biomedical Life Systems, Inc. · May 1985