FENIX GROUP S.R.L. · 89-08 · ITALY (Via Agostinone 9 , Montesilvano, Pescara ITALY)
For FENIX GROUP S.R.L. (Via Agostinone 9 , Montesilvano, Pescara ITALY), 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 Endospheres Device | Endospheres Device; product code is 79 N - - UV Massager, Vaccuum, light induced heating | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/27/2023; address is Via Agostinone 9 , Montesilvano, Pescara ITALY, verified against its source on 2026-09-30.
- Firm
- FENIX GROUP S.R.L. 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 Agostinone 9 , Montesilvano, Pescara ITALY verified
- Date published
- 11/27/2023 verified
- Product code
- 79 N - - UV Massager, Vaccuum, light induced heating | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Endospheres Device | Endospheres Device each item verified
What the source says
FENIX GROUP S.R.L. Date Published : 11/27/2023 Via Agostinone 9 , Montesilvano, Pescara 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 N - - UV Massager, Vaccuum, light induced heating Date Published: 11/27/2023 Desc: Endospheres Device 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/27/2023 Desc: Endospheres Device
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html