# ELETTRONICA PAGANI SRL · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For ELETTRONICA PAGANI SRL · 89-08 · ITALY, 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 ITALY; product is HC Cryo T-Shock | Cryoskin; product code is 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager; date published is 08/08/2022; address is Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY, verified against its source on 2026-09-16.

- **Firm:** ELETTRONICA PAGANI SRL _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY _(verified: appears in the quote below)_
- **Date published:** 08/08/2022 _(verified: appears in the quote below)_
- **Product code:** 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager _(verified: each item appears in the quote below)_
- **Product:** HC Cryo T-Shock | Cryoskin _(verified: each item appears in the quote below)_

## What the source says

> ELETTRONICA PAGANI SRL Date Published : 08/08/2022 Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 08/08/2022 Desc: HC Cryo T-Shock 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 08/08/2022 Desc: Cryoskin

## 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/).