Product Code: BRT FDA class 1 21 CFR 880.6760

Restraint, Patient, Conductive

General Hospital

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.

510(k)s
0
FEI Numbers
1
Registration Numbers
1
Unique Applicants
0
Years Active

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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

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

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.