FDA Device Intelligence
Home › IHEALTH LAB INC. › iHealth

iHealth

IHEALTH LAB INC. · Model ECG3 · UDI-DI 00856362005012

DSH
10
510(k) clearances
962
Adverse events (6 deaths)
0
Recalls
57
Facilities

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.