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

For UM 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 Hydromax Penis Pump | Hercules Penis Pump | Hercules Penis Pump | Hydromax Penis Pump; product code is 78 L - - KY Device, External Penile Rigidity | 78 L - - KY Device, External Penile Rigidity | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/07/2015; address is Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** UM 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:** Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 04/07/2015 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 78 L - - KY Device, External Penile Rigidity | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Hydromax Penis Pump | Hercules Penis Pump | Hercules Penis Pump | Hydromax Penis Pump _(verified: each item appears in the quote below)_

## What the source says

> UM Products Ltd Date Published : 04/07/2015 Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM 78 L - - KY Device, External Penile Rigidity Date Published: 04/07/2015 Desc: Hydromax Penis Pump 78 L - - KY Device, External Penile Rigidity Date Published: 04/07/2015 Desc: Hercules Penis Pump 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/07/2015 Desc: Hercules Penis Pump 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/07/2015 Desc: Hydromax Penis Pump

## 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/).