Device, Aversive Conditioning

Device Code: 3720

Product Code(s): HCB

Device Classification Information

Device Type ID3720
Device NameDevice, Aversive Conditioning
Regulation DescriptionAversive Conditioning Device.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurostimulation Devices Psychiatry Branch (NSDP)
Submission Type510(k)
CFR Regulation Number882.5235 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHCB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3720
DeviceDevice, Aversive Conditioning
Product CodeHCB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAversive Conditioning Device.
CFR Regulation Number882.5235 [🔎]
Device Problems
Coil
1
Positioning Failure
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:35:17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.