Reference Source

UM Products Ltd · 89-08 · UNITED KINGDOM

For UM Products Ltd, import alert is 89-08; country is UNITED KINGDOM; 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 Hydromax Penis Pump | Hercules Penis Pump | Hydromax Penis Pump | Hercules 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 2026-09-30.

Firm
UM Products 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
UNITED KINGDOM verified
Address
Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM verified
Date published
04/07/2015 verified
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 each item verified
Product
Hydromax Penis Pump | Hercules Penis Pump | Hydromax Penis Pump | Hercules Penis Pump each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— 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 and Product

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: Hydromax Penis Pump 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/07/2015 Desc: Hercules Penis Pump

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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