Certified Health Apps

All apps · Pain & neuromodulation

Certified pain management apps and devices

16 pain apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

13FDA verified
0CE class IIa or higher
1German DiGA
2no matching FDA record

Pain is an area where the FDA has authorised many new types of tools through the De Novo route: virtual reality for chronic back pain, an app for fibromyalgia, facial analysis to assess pain in people who cannot speak, and wearable nerve stimulators.

Below you find every pain and neuromodulation tool we track, grouped by what we could verify in the official registers.

In the US: FDA verified (13)

Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.

In Germany: DiGA (1)

Listed in the German directory of reimbursed digital health applications.

Watchlist (2)

These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.

The trap to avoid

TENS devices are sold everywhere, but not all are cleared, and many apps that pair with them are not named in any record. Check the device and the app, and check the indication: acute pain, chronic pain and fibromyalgia are different clearances.

Questions

Is virtual reality FDA authorised for pain?

Yes. EaseVRx was authorised through the De Novo route for chronic low back pain. In our directory, CognifiSense VRNT (2026) and Smileyscope (2023) also hold clearances.

Is there an FDA-authorised app for fibromyalgia?

Stanza, a digital therapy app, was authorised through the De Novo route in 2023. Quell Fibromyalgia, a wearable stimulator, also holds a De Novo authorisation.

Can pain be assessed in people who cannot speak?

PainChek uses facial analysis on a smartphone and is authorised through the De Novo route in our directory.

Is a pain app reimbursed in Germany?

HelloBetter Chronische Schmerzen is listed as a DiGA.

Certification status changes. Always confirm in the official register before relying on it. Not medical advice.

Search the full directory · Free guide: how to check a health app in two minutes