All apps · Sleep & breathing

Is Wellinks FDA approved or cleared?

Not as such. Wellinks Health holds a 510(k) clearance for related hardware, latest decision in 2020, but Wellinks itself is not named in the FDA record.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	Wellinks
Maker	Wellinks Health
Care area	Sleep & breathing
What it does	Digital pulmonary rehabilitation platform for COPD and lung disease management
FDA	510(k), latest decision 2020
Verification level	Related hardware authorised; this app itself is not named (checked 18 October 2026)
EU (CE)	No CE listing found
Website	wellinks.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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