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

For Gbo Medizin Tec · 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 is Quantron Resonance System (Body Stimulator); product code is 84 N - - HI Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief; date published is 03/09/2012; address is Litzel Rimbach , Rimbach, Hessen GERMANY, verified against its source on 2026-09-16.

- **Firm:** Gbo Medizin Tec _(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:** Litzel Rimbach , Rimbach, Hessen GERMANY _(verified: appears in the quote below)_
- **Date published:** 03/09/2012 _(verified: appears in the quote below)_
- **Product code:** 84 N - - HI Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief _(verified: appears in the quote below)_
- **Product:** Quantron Resonance System (Body Stimulator) _(verified: appears in the quote below)_
- **FDA notes:** class II _(verified: appears in the quote below)_

## What the source says

> Gbo Medizin Tec Date Published : 03/09/2012 Litzel Rimbach , Rimbach, Hessen GERMANY 84 N - - HI Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief Date Published: 03/09/2012 Desc: Quantron Resonance System (Body Stimulator) Notes: class II

## 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/).