# Electro Medica Office · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Electro Medica Office · 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 Sonafon Sonic Acupuncture; product code is 84 B - - WK Stimulator, Electro-Acupuncture; date published is 03/08/2011; address is Rr 2 , Burnt River, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** Electro Medica Office _(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:** Rr 2 , Burnt River, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 03/08/2011 _(verified: appears in the quote below)_
- **Product code:** 84 B - - WK Stimulator, Electro-Acupuncture _(verified: appears in the quote below)_
- **Product:** Sonafon Sonic Acupuncture _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Electro Medica Office Date Published : 03/08/2011 Rr 2 , Burnt River, Ontario CANADA 84 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Sonafon Sonic Acupuncture Notes: Class III

## 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/).