Data / Medical devices / Isle of Man / Bodystat Ltd
Bodystat Ltd: FDA-registered device maker in Isle of Man, Isle of Man, 4 510(k) clearances
Bodystat Ltd is registered with the FDA (registration 3006948217) in Isle of Man, Isle of Man. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 7, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006948217
- Address
- Chester House, Main Road Sulby, Isle of Man, Isle of Man, IM7 2HJ
- Owner or operator
- BodyStat Ltd (10024885)
- Roles
- Manufacturer
- First device listed
- January 6, 2009
- Registered through
- 2026
- Brand names listed
- Bodystat 1000, Bodystat 1500, Bodystat 1500MDD, Bodystat 500, Bodystat MultiScan 5000, QuadScan 4000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2011 | K082255 | QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT | MNW | Substantially Equivalent | Bodystat , Ltd. | accessdata.fda.gov |
| February 7, 2011 | K082254 | MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | MNW | Substantially Equivalent | Bodystat , Ltd. | accessdata.fda.gov |
| November 25, 2008 | K082253 | BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT | MNW | Substantially Equivalent | Bodystat , Ltd. | accessdata.fda.gov |
| November 26, 1997 | K971554 | BODYSTAT | MNW | Substantially Equivalent | Bodystat , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 7, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.