FDA product code OMV: Ultrasonic Body Composition Analyzer
OMV is the FDA product code for ultrasonic body composition analyzer. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under OMV. The average 510(k) review took 233 days (median 233).
Definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasonic Body Composition Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OMV clearance
Top OMV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intelametrix, Inc. | 1 | 2009-03-20 |
Most recent OMV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082147 | Intelametrix, Inc. | BODYMETRIX BX2000 | 2009-03-20 | 233 |
Recalls for OMV devices
openFDA lists no recalls for product code OMV.
Frequently asked questions
What is FDA product code OMV?
OMV is the FDA product code for ultrasonic body composition analyzer. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel.
What device class is OMV?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMV?
Across 1 cleared submissions the average was 233 days from receipt to decision (median 233).
Which companies have the most OMV clearances?
Intelametrix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMV
- Run a recall and safety report across every OMV manufacturer
- Watch product code OMV 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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