# ORBISAN LTD · 89-08 · MALTA — FDA import alert red lists: firms subject to detention without physical examination

For ORBISAN LTD · 89-08 · MALTA, 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 MALTA; product is Penis Extender | Penis Extender | Penis Extender | Penis Extender; product code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) | 89 I - - SA Massager, Therapeutic, Electric; date published is 05/23/2012; address is Ub3a Industrial Estate , San Gwann, San Gwann MALTA, verified against its source on 2026-09-16.

- **Firm:** ORBISAN LTD _(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:** MALTA _(verified: appears in the quote below)_
- **Address:** Ub3a Industrial Estate , San Gwann, San Gwann MALTA _(verified: appears in the quote below)_
- **Date published:** 05/23/2012 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical | 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Penis Extender | Penis Extender | Penis Extender | Penis Extender _(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

> ORBISAN LTD Date Published : 05/23/2012 Ub3a Industrial Estate , San Gwann, San Gwann MALTA 78 L - - KY Device, External Penile Rigidity Date Published: 05/23/2012 Desc: Penis Extender Notes: Class II 78 N - - HU Extender, Penile, Mechanical Date Published: 05/23/2012 Desc: Penis Extender Notes: class II 79 B - - TA Pump, Portable, Aspiration (Manual Or Powered) Date Published: 05/23/2012 Desc: Penis Extender Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/23/2012 Desc: Penis Extender 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/).