# Ultramax Products Ltd · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Ultramax Products Ltd · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is Penis Pump; product code is 78 L - - KY Device, External Penile Rigidity; date published is 06/15/2010; address is Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Ultramax Products 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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 06/15/2010 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity _(verified: appears in the quote below)_
- **Product:** Penis Pump _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Ultramax Products Ltd Date Published : 06/15/2010 Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM 78 L - - KY Device, External Penile Rigidity Date Published: 06/15/2010 Desc: Penis Pump Notes: 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/).