Neuro-Fitness LLC CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
Brand
Neuro-Fitness LLC
Lot Codes / Batch Numbers
Serial Numbers: 1000 through 3999.
Products Sold
Serial Numbers: 1000 through 3999.
Neuro-Fitness LLC is recalling CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Ar due to No FDA clearance for the .35Hz/.45Hz frequency option on device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
No FDA clearance for the .35Hz/.45Hz frequency option on device.
Recommended Action
Per FDA guidance
Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026