Pierenkemper Gmbh · 89-08 · GERMANY
For Pierenkemper Gmbh, 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 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 2026-09-30.
- 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
— 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 and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html