Neuro-Fitness LLC

Fall City, WA, US

NEURO-FITNESS LLC appears in FDA device records in Fall City, WA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Neuro-Fitness LLC in 2007.

Clearances by year, as a table

510(k) clearance decisions for Neuro-Fitness LLC, by decision year
Year	Clearances
2007	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K062284	CES ULTRA	QJQ	Substantially Equivalent	2007-04-05

Registered establishments

FDA registered establishments for Neuro-Fitness LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3005026995	3005026995	NEURO-FITNESS LLC	36002 SE 49th St, FALL CITY, WA 98024 US	2026	QJQ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0712-2008	CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024	No FDA clearance for the .35Hz/.45Hz frequency option on device.		2007-10-29	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain