Pierenkemper Gmbh · 89-08 · GERMANY
For Pierenkemper Gmbh · 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 Flexpulse | Flexpulse | Flexpulse; product code is 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 06/04/2019; address is Wetzlarer Str. 41-43 , Ehringshausen, Hassia GERMANY, verified against its source on 2026-09-16.
- Firm
- Pierenkemper Gmbh 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
- Wetzlarer Str. 41-43 , Ehringshausen, Hassia GERMANY verified
- Date published
- 06/04/2019 verified
- Product code
- 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use | 89 I - - SA Massager, Therapeutic, Electric | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
- Product
- Flexpulse | Flexpulse | Flexpulse each item verified
What the source says
Pierenkemper Gmbh Date Published : 06/04/2019 Wetzlarer Str. 41-43 , Ehringshausen, Hassia GERMANY 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 06/04/2019 Desc: Flexpulse 89 I - - SA Massager, Therapeutic, Electric Date Published: 06/04/2019 Desc: Flexpulse 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 06/04/2019 Desc: Flexpulse
— 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.