510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971143Substantially Equivalent

Neuro Pulse Ii,iii

Apyx Medical Corporation, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971143 is the FDA 510(k) clearance record for NEURO PULSE II,III, a class II device, cleared for Aaron Medical Industries on under FDA product code ETN (Stimulator, Nerve). FDA records list 75 510(k) clearances for Apyx Medical Corporation, from to . As of , FDA records show no recalls naming K971143.

Clearance record

Decision date
Received
(70 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Aaron Medical Industries 7100 30th Ave. N, St. Petersburg FL
510(k) summary
Statement
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260