Is MY01 FDA approved or cleared?
Yes. MY01 by MY01 Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2026.
In the EU: CE class I (self-declared by the maker).
At a glance
| Product | MY01 |
|---|---|
| Maker | MY01 Inc. |
| Care area | Muscles, bones & rehab |
| What it does | Continuous compartment pressure monitor with mobile app to detect acute compartment syndrome |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class I (self-declared) |
| Website | my01.io |
| Status | FDA verified |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes