FDA product code QSB: Orthosis, Truncal, Pregnancy
QSB is the FDA product code for orthosis, truncal, pregnancy. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under QSB. The average 510(k) review took 38 days (median 38).
Definition
Provide abdominal and back support during pregnancy
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Truncal, Pregnancy |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every QSB clearance
Top QSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Body Therapeutics, Inc. | 1 | 1982-07-30 |
Most recent QSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821836 | Body Therapeutics, Inc. | PREGNANCY (W) EDGE | 1982-07-30 | 38 |
Recalls for QSB devices
openFDA lists no recalls for product code QSB.
Frequently asked questions
What is FDA product code QSB?
QSB is the FDA product code for orthosis, truncal, pregnancy. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Obstetrics and Gynecology panel.
What device class is QSB?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QSB?
Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most QSB clearances?
Body Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSB
- Run a recall and safety report across every QSB manufacturer
- Watch product code QSB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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