Gbo Medizin Tec · 89-08 · GERMANY
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
- 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
- Address
- Litzel Rimbach , Rimbach, Hessen GERMANY verified
- Date published
- 03/09/2012 verified
- Product code
- 84 N - - HI Nerve, Stimulator, Electrical, Percutaneous (PENS) for Pain Relief verified
- Product
- Quantron Resonance System (Body Stimulator) verified
- FDA notes
- class II verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.