510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220059Unknown

NTX100 Tonic Motor Activation (NTX100 ToMAc) System

Noctrix Health, Inc., Pleasanton CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220059 is the FDA 510(k) clearance record for NTX100 Tonic Motor Activation (NTX100 ToMAc) System, a class II device, cleared for Noctrix Health, Inc. on under FDA product code QWD (Stimulator, Nerve, For Restless Legs Syndrome). FDA's definition for product code QWD reads: "An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke...". FDA records list one 510(k) clearance for Noctrix Health, Inc. As of , FDA records show no recalls naming DEN220059.

Clearance record

Decision date
Received
(208 days to decision)
Product code
QWD Stimulator, Nerve, For Restless Legs Syndrome
Regulation
21 CFR 882.5887
Device class
Class II
Review panel
Neurology
Applicant
Noctrix Health, Inc. 6700 Koll Center Pkwy., Suite 310, Pleasanton CA
Third party review
No

Clearances, product code QWD

Trailing 12 months

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

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