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

For Binder International · 89-08 · GERMANY, 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 GERMANY; product code is 84 H - - CC Device, Biofeedback; date published is 09/16/2009; address is Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

- **Firm:** Binder 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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 84 H - - CC Device, Biofeedback _(verified: appears in the quote below)_
- **FDA notes:** Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval. _(verified: appears in the quote below)_

## What the source says

> Binder International Date Published : 09/16/2009 Otto-Hahn-Str. 19 , Herrenberg, Baden-Wurttemberg GERMANY 84 H - - CC Device, Biofeedback Date Published: 09/16/2009 Notes: Ondamned System Regulation (Biofeedback Device) 4/29/2003 Lack of 510(k) Approval.

## 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/).