Electro Medica Office · 89-08 · CANADA
For Electro Medica Office, 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 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 2026-09-30.
- Firm
- Electro Medica Office 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
- Rr 2 , Burnt River, Ontario CANADA verified
- Date published
- 03/08/2011 verified
- Product code
- 84 B - - WK Stimulator, Electro-Acupuncture verified
- Product
- Sonafon Sonic Acupuncture verified
- FDA notes
- Class III verified
What the source says
Electro Medica Office Date Published : 03/08/2011 Rr 2 , Burnt River, Ontario CANADA
— accessdata.fda.gov, retrieved 2026-09-15
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
84 B - - WK Stimulator, Electro-Acupuncture Date Published: 11/08/2018 Desc: Sonafon Sonic Acupuncture Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.