Cleared Traditional

K971143 - NEURO PULSE II,III

K971143 is an FDA 510(k) clearance for NEURO PULSE II, manufactured by Aaron Medical Industries. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K971143 · Aaron Medical Industries · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
70d
Days
Class 2
Risk

K971143 is an FDA 510(k) clearance for the NEURO PULSE II,III. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat 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 Aaron Medical Industries devices

FDA 510(k) Submission Details - K971143

510(k) Number K971143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date June 06, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 90d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 62
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K971143.
NIM4
K982595 · Xomed, Inc. · Sep 1998
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K980148 · The Magstim Company , Ltd. · Aug 1998
URO MED NERVE STIMULATOR
K970971 · Uromed Corp. · Oct 1997
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K964869 · The Magstim Company , Ltd. · May 1997
STIMULATING SURGICAL INSTRUMENTS
K934733 · Smith & Nephew Richards, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · R & D Batteries, Inc. · Nov 1993