Cleared Traditional

K830792 - PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE

K830792 is an FDA 510(k) clearance for PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE, manufactured by Bomed Medical Mfr., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K830792 · Bomed Medical Mfr., Ltd. · Neurology device
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Mar 1983
Decision
15d
Days
Class 2
Risk

K830792 is an FDA 510(k) clearance for the PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bomed Medical Mfr., Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 15 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 Bomed Medical Mfr., Ltd. devices

FDA 510(k) Submission Details - K830792

510(k) Number K830792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date March 29, 1983
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
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 K830792.
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K831950 · Spembly Medical , Ltd. · Aug 1983
SPEC IISX
K831413 · Medical Devices, Inc. · Jun 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · Tri W-G, Inc. · Nov 1982