Cleared Traditional

K851735 - SYS STIM 206 MODEL ME206

K851735 is an FDA 510(k) clearance for SYS STIM 206 MODEL ME206, manufactured by Mettler Electronics Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K851735 · Mettler Electronics Corp. · Neurology device
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Nov 1985
Decision
208d
Days
Class 2
Risk

K851735 is an FDA 510(k) clearance for the SYS STIM 206 MODEL ME206. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 208 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.

FDA 510(k) Submission Details - K851735

510(k) Number K851735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date November 19, 1985
Days to Decision 208 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 149d · This submission: 208d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K851735.
NEURO PULSE II
K853836 · Nagata Engineering Co. · Dec 1985
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
K853718 · Electro Therapeutic Devices, Inc. · Dec 1985
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410
K853719 · Electro Therapeutic Devices, Inc. · Dec 1985
MES-TENS(TENS)
K853416 · Oriental Medical Supplies, Inc. · Nov 1985
ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
K852836 · Advanced Medical Products, Inc. · Aug 1985
ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
K852837 · Advanced Medical Products, Inc. · Aug 1985
K851735 · SYS STIM 206 MODEL ME206
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