Restraint, Patient, Conductive
The Restraint, Patient, Conductive is a hospital device used to physically restrain patients during medical procedures while allowing safe dissipation of static electrical charges. It is classified as FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards, with no premarket submission required. The product code is BRT and it is regulated under 21 CFR 880.6760, falling within the General Hospital medical specialty.
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Basic Information
- Product Code
- BRT
- Device Class
- FDA class 1
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.