Planet Earth Logis · 89-08 · UNITED KINGDOM
For Planet Earth Logis, 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 Penis Extender | Cock Ring | 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 2026-09-30.
- 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
- Penis Extender | Cock Ring | Breast Pump | Breast Pump each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
What the source says
Planet Earth Logis Date Published : 08/26/2012 184 Horbury Road , Wakefield, West Yorkshire 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, Product and FDA notes
78 L - - KY Device, External Penile Rigidity Date Published: 08/26/2012 Desc: Penis Extender Notes: Class II 78 L - - KY Device, External Penile Rigidity Date Published: 08/26/2012 Desc: Cock Ring 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html