510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QSBClass I

Orthosis, Truncal, Pregnancy

21 CFR 890.3490 / Physical Medicine
FDA source (opens on fda.gov)

QSB is the FDA product code for Orthosis, Truncal, Pregnancy, a class I device type, regulated under 21 CFR 890.3490. FDA's definition for this code reads: "Provide abdominal and back support during pregnancy". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QSB
Device name
Orthosis, Truncal, Pregnancy
FDA definition
Provide abdominal and back support during pregnancy
Regulation
21 CFR 890.3490
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QSB

By decision year
1 clearance under product code QSB with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QSB by decision year
YearClearances
19821

Applicants with the most clearances

Product code QSB
Applicants holding the most 510(k) clearances under product code QSB
ApplicantClearances
Body Therapeutics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code