← FDA Medical Device Classifications

Orthosis, Truncal, Pregnancy

QSB · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3490

Classification

FDA Product Code
QSB
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.3490
Review panel
OB
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Provide abdominal and back support during pregnancy

Market data

Cleared 510(k) submissions
1
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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