# Tomatis International · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For Tomatis International · 89-08 · FRANCE, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is FRANCE; product code is 84 G - - WJ Stimulator, Auditory, Evoked Response; date published is 09/16/2009; address is 6 Pl de la Republique Dominicaine , Paris, Paris FRANCE, verified against its source on 2026-09-16.

- **Firm:** Tomatis International _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** FRANCE _(verified: appears in the quote below)_
- **Address:** 6 Pl de la Republique Dominicaine , Paris, Paris FRANCE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 84 G - - WJ Stimulator, Auditory, Evoked Response _(verified: appears in the quote below)_
- **FDA notes:** Electronic Ear or any deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997 _(verified: appears in the quote below)_

## What the source says

> Tomatis International Date Published : 09/16/2009 6 Pl de la Republique Dominicaine , Paris, Paris FRANCE 84 G - - WJ Stimulator, Auditory, Evoked Response Date Published: 09/16/2009 Notes: Electronic Ear or any deviced labled or marked for auditory training; auditory integration; or behavioral improvement. 2/5/1997

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).