NEW FDA REGULATIONS FOR ELECTRODE LEADS



AUTOGENICS
Harvard Square Cambridge, MA 02238

 
 



NEW FDA REGULATIONS FOR ELECTRODE LEADS



New Federal Food and Drug Administration regulations regarding electrode leads used with biofeedback equipment are now in effect. The instrument you purchased may have a different type of lead connection than shown in the user manual. All leads are now wired directly into the instrument to prevent accidental connection of the leads to a 120V AC outlet. The instrument will function just the same as with the older plug in leads.

The following Autogenics products are affected:

Model AT 33: Single Channel EMG. Electrode lead wired into unit.

Model AT 42: Temperature. Electrode lead wired into unit with safety plug for sensor.
Model AT 53: Two Channel EMG. Both leads wired into unit.

Model AT 64: SCR: Electrode lead wired into unit.

Model AT 62: EEG Unit: Headphones eliminated. Standard electrode lead wired into unit. Provided with Safe Lead Gold Ear and Scalp Electrodes.

Older AT Units
While the FDA does not require a recall of the older units they will not allow the sale of replacement cables for these instruments. Autogenics will modify the older AT instruments for a fee plus return shipping. Please call for a quote on your instrument.. The old leads must be returned with the units to complete the modification.
Please contact Autogenics directly if you have any questions on the new FDA Electrode Regulations.

 

 


 
 

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