Reference Source

Oa Internet Svcs Ltd · 89-08 · CANADA

For Oa Internet Svcs Ltd, 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 Vimax System | Andro Penis Extender | Andro Penis Extender | Vimax System; 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 2026-09-30.

Firm
Oa Internet Svcs Ltd 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
5764 Av De Monkland , Montreal, Quebec CANADA verified
Date published
11/28/2011 verified
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 each item verified
Product
Vimax System | Andro Penis Extender | Andro Penis Extender | Vimax System each item verified
FDA notes
Class II | Class II | Class II | Class II; 11/28/2011 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

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

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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