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

For Ultragen 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 Tripollar POSE; Tripollar STOP; product code is 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 08/02/2011; address is 6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL, verified against its source on 2026-09-16.

- **Firm:** Ultragen 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 , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL _(verified: appears in the quote below)_
- **Date published:** 08/02/2011 _(verified: appears in the quote below)_
- **Product code:** 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat _(verified: appears in the quote below)_
- **Product:** Tripollar POSE; Tripollar STOP _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Ultragen Ltd Date Published : 08/02/2011 6 Kaufman Street , Gabor House, Po Box 50320 , Tel Aviv, ISRAEL 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 08/02/2011 Desc: Tripollar POSE; Tripollar STOP Notes: Class II

## 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/).