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

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: 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:** 9008 51 Ave NW , Edmonton, Alberta CANADA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 84 J - - XK Cranial electrotherapy stimulator to treat depression _(verified: appears in the quote below)_
- **FDA notes:** 6/29/2000 Oasis Cranial Electrotherapy Stimulator (CES) _(verified: appears in the quote below)_

## 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)

## 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/).