# Planet Earth Logis · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** 184 Horbury Road , Wakefield, West Yorkshire UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 08/26/2012 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Cock Ring | Penis Extender | Breast Pump | Breast Pump _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## 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

## 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/).