Pollogen Ltd · 89-08 · ISRAEL
For Pollogen Ltd, import alert is 89-08; country is ISRAEL; 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 Pollogen Apollo; product code is 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat; date published is 09/16/2009; address is 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL, verified against its source on 2026-09-30.
- Firm
- Pollogen Ltd 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
- ISRAEL verified
- Address
- 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL verified
- Date published
- 09/16/2009 verified
- Product code
- 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat each item verified
- Product
- Pollogen Apollo verified
- FDA notes
- Pollogen Regan; 5/12/2009; Class III | Class III; 5/12/2009 each item verified
What the source says
Pollogen Ltd Date Published : 09/16/2009 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL
— accessdata.fda.gov, retrieved 2026-09-22
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
89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 09/16/2009 Notes: Pollogen Regan; 5/12/2009; Class III 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 06/29/2018 Desc: Pollogen Apollo Notes: Class III; 5/12/2009
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html