# Innovatech Designs · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Innovatech Designs · 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 code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical; date published is 09/29/2009; address is Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA, verified against its source on 2026-09-16.

- **Firm:** Innovatech Designs _(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:** Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA _(verified: appears in the quote below)_
- **Date published:** 09/29/2009 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical _(verified: each item appears in the quote below)_
- **FDA notes:** Class III; 3/5/09 | Class III; 3/5/09 _(verified: each item appears in the quote below)_

## What the source says

> Innovatech Designs Date Published : 09/29/2009 Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA 78 L - - KY Device, External Penile Rigidity Date Published: 09/29/2009 Notes: Class III; 3/5/09 78 N - - HU Extender, Penile, Mechanical Date Published: 09/29/2009 Notes: Class III; 3/5/09

## 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/).