ORBISAN LTD · 89-08 · MALTA
For ORBISAN LTD, import alert is 89-08; country is MALTA; 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 | 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 2026-09-30.
- Firm
- ORBISAN 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
- MALTA verified
- Address
- Ub3a Industrial Estate , San Gwann, San Gwann MALTA verified
- Date published
- 05/23/2012 verified
- 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 each item verified
- Product
- Penis Extender | Penis Extender | Penis Extender | Penis Extender each item verified
- FDA notes
- Class II | class II | Class II | class II each item verified
What the source says
ORBISAN LTD Date Published : 05/23/2012 Ub3a Industrial Estate , San Gwann, San Gwann MALTA
— accessdata.fda.gov, retrieved 2026-09-15
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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html