Gbo Medizin Tec · 89-08 · GERMANY
For Gbo Medizin Tec, import alert is 89-08; country is GERMANY; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html