Device Type ID | 3720 |
Device Name | Device, Aversive Conditioning |
Regulation Description | Aversive Conditioning Device. |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
Submission Type | 510(k) |
CFR Regulation Number | 882.5235 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HCB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3720 |
Device | Device, Aversive Conditioning |
Product Code | HCB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Aversive Conditioning Device. |
CFR Regulation Number | 882.5235 [🔎] |
Device Problems | |
---|---|
Coil | 1 |
Positioning Failure | 1 |
Total Device Problems | 2 |