Medicalium Energies & Health · 89-08 · SPAIN
For Medicalium Energies & Health · 89-08 · SPAIN, 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 SPAIN; product is HR3 Cap | Presojet Pressure Massage; product code is 79 F - - TC Light, Ultraviolet, Dermatological | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite; date published is 10/08/2019; address is Calle Pasteur 57 E , Terrassa, Barcelona SPAIN, verified against its source on 2026-09-16.
- Firm
- Medicalium Energies & Health 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
- SPAIN verified
- Address
- Calle Pasteur 57 E , Terrassa, Barcelona SPAIN verified
- Date published
- 10/08/2019 verified
- Product code
- 79 F - - TC Light, Ultraviolet, Dermatological | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite each item verified
- Product
- HR3 Cap | Presojet Pressure Massage each item verified
- FDA notes
- Class II device without a valid 510(k). | Class II device without a valid 510(k). each item verified
What the source says
Medicalium Energies & Health Date Published : 10/08/2019 Calle Pasteur 57 E , Terrassa, Barcelona SPAIN 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/08/2019 Desc: HR3 Cap Notes: Class II device without a valid 510(k). 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite Date Published: 10/08/2019 Desc: Presojet Pressure Massage Notes: Class II device without a valid 510(k).
— 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.