510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230826Substantially Equivalent

Modius Sleep

Neurovalens, Portglenone, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230826 is the FDA 510(k) clearance record for Modius Sleep, a class II device, cleared for Neurovalens , Ltd. on under FDA product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety). FDA's definition for product code QJQ reads: "To provide electrical current to the head to treat insomnia and/or anxiety". FDA records list 4 510(k) clearances for Neurovalens , Ltd., from to . As of , FDA records show no recalls naming K230826.

Clearance record

Decision date
Received
(217 days to decision)
Product code
QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Regulation
21 CFR 882.5800
Device class
Class II
Review panel
Neurology
Applicant
Neurovalens , Ltd. 8 Carmagrim Rd., Portglenone, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJQ

Trailing 12 months
1 clearance under product code QJQ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QJQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260