# X4 Labs Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For X4 Labs Inc. · 89-08 · CANADA, 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 CANADA; product is Any Penile Corrective Devices | X4 Penile corrective device | Any Penile Corrective Devices; product code is 78 L - - KY Device, External Penile Rigidity | 78 L - - -- Portion of device code | 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 2026-09-16.

- **Firm:** X4 Labs Inc. _(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:** CANADA _(verified: appears in the quote below)_
- **Address:** 6855 De L'Epee Ave. , Montreal, QC CANADA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 78 L - - -- Portion of device code | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code _(verified: each item appears in the quote below)_
- **Product:** Any Penile Corrective Devices | X4 Penile corrective device | Any Penile Corrective Devices _(verified: each item appears in the quote below)_
- **FDA notes:** x4 Penile corrective device. 9/16/2008 | Class III | 9/16/2008 | Class III _(verified: each item appears in the quote below)_

## What the source says

> X4 Labs Inc. Date Published : 09/16/2009 6855 De L'Epee Ave. , Montreal, QC CANADA 78 L - - KY Device, External Penile Rigidity Date Published: 09/16/2009 Notes: x4 Penile corrective device. 9/16/2008 78 L - - -- 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 78 N - - -- Portion of device code Date Published: 09/20/2011 Desc: Any Penile Corrective Devices Notes: Class III

## 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/).