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NEURALYNX, INC.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Global Reference Module 4	Global Reference Module - 4	FDA UDI	Class II	Active
Atlas-Hs-36-Chet-Idc10	ATLAS-HS-36-CHET-IDC10	FDA UDI	Class II	Unknown
Fiber Optic Connector 7m	7m	FDA UDI	Class II	Active
Remote Monitoring System	1.0.0	FDA UDI	Class II	Unknown
DIXI Adapter	DIXI Adapter	FDA UDI	Class II	Active
Enterprise Electrophysiology System	K110967	FDA 510(k)	Class II	Active
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)	K250094	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 14, 2022	Z-1091-2022	—	open, classified	Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.