# Medicalium Energies & Health · 89-08 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Calle Pasteur 57 E , Terrassa, Barcelona SPAIN _(verified: appears in the quote below)_
- **Date published:** 10/08/2019 _(verified: appears in the quote below)_
- **Product code:** 79 F - - TC Light, Ultraviolet, Dermatological | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite _(verified: each item appears in the quote below)_
- **Product:** HR3 Cap | Presojet Pressure Massage _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510(k). | Class II device without a valid 510(k). _(verified: each item appears in the quote below)_

## 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).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).