UM Products Ltd · 89-08 · UNITED KINGDOM
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
- 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 | Hercules Penis Pump | Hydromax Penis Pump each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html