Reference Source

Comptronics Devices Limited · 89-08 · CANADA

For Comptronics Devices Limited · 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 84 J - - XK Cranial electrotherapy stimulator to treat depression; date published is 09/16/2009; address is 9008 51 Ave NW , Edmonton, Alberta CANADA, verified against its source on 2026-09-16.

Firm
Comptronics Devices Limited 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
9008 51 Ave NW , Edmonton, Alberta CANADA verified
Date published
09/16/2009 verified
Product code
84 J - - XK Cranial electrotherapy stimulator to treat depression verified
FDA notes
6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES) verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Comptronics Devices Limited Date Published : 09/16/2009 9008 51 Ave NW , Edmonton, Alberta CANADA 84 J - - XK Cranial electrotherapy stimulator to treat depression Date Published: 09/16/2009 Notes: 6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES)

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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