510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240076Unknown

Modius Lean

Neurovalens, Portglenone, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN240076 is the FDA 510(k) clearance record for Modius Lean, a class I device, cleared for Neurovalens Limited on under FDA product code SFW (Cranial Electrotherapy Stimulator For Weight Management). FDA's definition for product code SFW reads: "A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and...". FDA records list 4 510(k) clearances for Neurovalens Limited, from to . As of , FDA records show no recalls naming DEN240076.

Clearance record

Decision date
Received
(303 days to decision)
Product code
SFW Cranial Electrotherapy Stimulator For Weight Management
Regulation
21 CFR 876.5984
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Neurovalens Limited 8 Carmagrim Rd., Portglenone, GB
Third party review
No

Clearances, product code SFW

Trailing 12 months

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

FDA records show no clearances under product code SFW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFW, 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