ELETTRONICA PAGANI SRL · 89-08 · ITALY
For ELETTRONICA PAGANI SRL, import alert is 89-08; country is ITALY; 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 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 2026-09-30.
- Firm
- ELETTRONICA PAGANI SRL 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
- ITALY verified
- Address
- Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY verified
- Date published
- 08/08/2022 verified
- 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 each item verified
- Product
- HC Cryo T-Shock | Cryoskin each item verified
What the source says
ELETTRONICA PAGANI SRL Date Published : 08/08/2022 Via Enrico De Nicola 4d , Paderno Dugnano, Milan ITALY
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html