510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130022Unknown

Neuralieve Cerena Transcranial Magnetic Stimulator

Eneura Therapeutics, Orono MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN130022 is the FDA 510(k) clearance record for NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR, a class II device, cleared for Eneura Therapeutics on under FDA product code OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache). FDA's definition for product code OKP reads: "Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric...". FDA records list 2 510(k) clearances for Eneura Therapeutics, from to . As of , FDA records show no recalls naming DEN130022.

Clearance record

Decision date
Received
(283 days to decision)
Product code
OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Regulation
21 CFR 882.5808
Device class
Class II
Review panel
Neurology
Applicant
Eneura Therapeutics 2690 Pheasant Rd., Orono MN
Third party review
No

Clearances, product code OKP

Trailing 12 months

FDA records hold no clearances under product code OKP in the trailing twelve months.

FDA records show no clearances under product code OKP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OKP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260