Product Code: MFR

Stimulator, Brain, Implanted, For Behavior Modification

Unknown

The implanted brain stimulator for behavior modification is a neurosurgically placed device that delivers electrical stimulation to specific brain structures with the intent of modifying behavior, representing an experimental and high-risk neuromodulation application. It carries a device class designation of "f" indicating it is a banned device, as the FDA has determined there is unreasonable and substantial risk of illness or injury that cannot be corrected through performance standards or labeling. The product code is MFR and it carries an implant flag; no regulation number or formal medical specialty has been assigned.

510(k)s
0
FEI Numbers
5
Registration Numbers
5
Unique Applicants
0
Years Active

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Basic Information

Product Code
MFR
Medical Specialty
Unknown
Review Panel
NE
Submission Type
6

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.