Biotronics Research Corporation · 89-08 · CANADA
For Biotronics Research Corporation, 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 Bone Growth Stimulator | Bone Growth Stimulator; product code is 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive; date published is 09/16/2009; address is 1104-3760 Albert Street , Burnaby, BC CANADA, verified against its source on 2026-09-30.
- Firm
- Biotronics Research Corporation 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
- 1104-3760 Albert Street , Burnaby, BC CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 87 L - - OE Stimulator, invasive bone growth | 87 L - - OF Stimulator, bone growth, non-invasive each item verified
- Product
- Bone Growth Stimulator | Bone Growth Stimulator each item verified
- FDA notes
- Class III; 10/28/2005 | Class III; 10/28/2005 each item verified
What the source says
Biotronics Research Corporation Date Published : 09/16/2009 1104-3760 Albert Street , Burnaby, BC 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
87 L - - OE Stimulator, invasive bone growth Date Published: 01/23/2019 Desc: Bone Growth Stimulator Notes: Class III; 10/28/2005 87 L - - OF Stimulator, bone growth, non-invasive Date Published: 01/23/2019 Desc: Bone Growth Stimulator Notes: Class III; 10/28/2005
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html