# Pollogen Ltd · 89-08 · ISRAEL — FDA import alert red lists: firms subject to detention without physical examination

For Pollogen Ltd · 89-08 · ISRAEL, 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 ISRAEL; 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 2026-09-16.

- **Firm:** Pollogen Ltd _(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:** ISRAEL _(verified: appears in the quote below)_
- **Address:** 6 Kaufman Street (main) T , 6 Kaudmann st. Gibor House, P O Box 50320 , Tel Aviv, ISRAEL _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Pollogen Apollo _(verified: appears in the quote below)_
- **FDA notes:** Class III; 5/12/2009 | Pollogen Regan; 5/12/2009; Class III _(verified: each item appears in the quote below)_

## 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 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 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

## 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/).