510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002889Substantially Equivalent

Pns Magnetic Stimulator System

Neotonus, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002889 is the FDA 510(k) clearance record for PNS MAGNETIC STIMULATOR SYSTEM, a class II device, cleared for Neotonus, Inc. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 4 510(k) clearances for Neotonus, Inc., from to . As of , FDA records show no recalls naming K002889.

Clearance record

Decision date
Received
(203 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Neotonus, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260