Innovatech Designs · 89-08 · CANADA
For Innovatech Designs, 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 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 2026-09-30.
- Firm
- Innovatech Designs 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
- Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA verified
- Date published
- 09/29/2009 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical each item verified
- FDA notes
- Class III; 3/5/09 | Class III; 3/5/09 each item verified
What the source says
Innovatech Designs Date Published : 09/29/2009 Dollards Des Ormeaux, Pq , 460 Hampton Court St , Dollard-Des-Ormeaux, Quebec CANADA
— 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 and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html