# Oa Internet Svcs Ltd · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Oa Internet Svcs Ltd · 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 Andro Penis Extender | Vimax System | Vimax System | Andro Penis Extender; product code is 78 L - - -- Portion of device code | 78 L - - -- Portion of device code | 78 N - - -- Portion of device code | 78 N - - -- Portion of device code; date published is 11/28/2011; address is 5764 Av De Monkland , Montreal, Quebec CANADA, verified against its source on 2026-09-16.

- **Firm:** Oa Internet Svcs Ltd _(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:** 5764 Av De Monkland , Montreal, Quebec CANADA _(verified: appears in the quote below)_
- **Date published:** 11/28/2011 _(verified: appears in the quote below)_
- **Product code:** 78 L - - -- Portion of device code | 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:** Andro Penis Extender | Vimax System | Vimax System | Andro Penis Extender _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II; 11/28/2011 | Class II _(verified: each item appears in the quote below)_

## What the source says

> Oa Internet Svcs Ltd Date Published : 11/28/2011 5764 Av De Monkland , Montreal, Quebec CANADA 78 L - - -- Portion of device code Date Published: 11/28/2011 Desc: Andro Penis Extender Notes: Class II 78 L - - -- Portion of device code Date Published: 11/28/2011 Desc: Vimax System Notes: Class II 78 N - - -- Portion of device code Date Published: 06/04/2019 Desc: Vimax System Notes: Class II; 11/28/2011 78 N - - -- Portion of device code Date Published: 11/28/2011 Desc: Andro Penis Extender Notes: Class II

## 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/).