Medicalium Energies & Health · 89-08 · SPAIN
For Medicalium Energies & Health, import alert is 89-08; country is SPAIN; 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 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 2026-09-30.
- 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
— 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
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).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html