Reference Source

Planet Earth Logis · 89-08 · UNITED KINGDOM

For Planet Earth Logis · 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 Cock Ring | Penis Extender | Breast Pump | Breast Pump; product code is 78 L - - KY Device, External Penile Rigidity | 78 L - - KY Device, External Penile Rigidity | 85 H - - GX Pump, Breast, Powered | 85 O - - HH Breast pump kit; date published is 08/26/2012; address is 184 Horbury Road , Wakefield, West Yorkshire UNITED KINGDOM, verified against its source on 2026-09-16.

Firm
Planet Earth Logis 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
184 Horbury Road , Wakefield, West Yorkshire UNITED KINGDOM verified
Date published
08/26/2012 verified
Product code
78 L - - KY Device, External Penile Rigidity | 78 L - - KY Device, External Penile Rigidity | 85 H - - GX Pump, Breast, Powered | 85 O - - HH Breast pump kit each item verified
Product
Cock Ring | Penis Extender | Breast Pump | Breast Pump each item verified
FDA notes
Class II | Class II | Class II | Class II 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

Planet Earth Logis Date Published : 08/26/2012 184 Horbury Road , Wakefield, West Yorkshire UNITED KINGDOM 78 L - - KY Device, External Penile Rigidity Date Published: 08/26/2012 Desc: Cock Ring Notes: Class II 78 L - - KY Device, External Penile Rigidity Date Published: 08/26/2012 Desc: Penis Extender Notes: Class II 85 H - - GX Pump, Breast, Powered Date Published: 08/26/2012 Desc: Breast Pump Notes: Class II 85 O - - HH Breast pump kit Date Published: 08/26/2012 Desc: Breast Pump Notes: Class II

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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