X4 Labs Inc. · 89-08 · CANADA
For X4 Labs Inc., import alert is 89-08; country is CANADA; 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 Any Penile Corrective Devices | Any Penile Corrective Devices | X4 Penile corrective device; product code is 78 L - - -- Portion of device code | 78 L - - KY Device, External Penile Rigidity | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code; date published is 09/16/2009; address is 6855 De L'Epee Ave. , Montreal, QC CANADA, verified against its source on 2026-09-30.
- Firm
- X4 Labs Inc. 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
- CANADA verified
- Address
- 6855 De L'Epee Ave. , Montreal, QC CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 78 L - - -- Portion of device code | 78 L - - KY Device, External Penile Rigidity | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code each item verified
- Product
- Any Penile Corrective Devices | Any Penile Corrective Devices | X4 Penile corrective device each item verified
- FDA notes
- Class III | x4 Penile corrective device. 9/16/2008 | Class III | 9/16/2008 each item verified
What the source says
X4 Labs Inc. Date Published : 09/16/2009 6855 De L'Epee Ave. , Montreal, QC CANADA
— 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 - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III 78 L - - KY Device, External Penile Rigidity Date Published: 09/16/2009 Notes: x4 Penile corrective device. 9/16/2008 78 N - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III 78 N - - -- Portion of device code Date Published: 09/06/2024 Desc: X4 Penile corrective device Notes: 9/16/2008
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html