Medec Pty Ltd · 89-08 · AUSTRALIA
For Medec Pty Ltd, import alert is 89-08; country is AUSTRALIA; 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 code is 89 I - - SA Massager, Therapeutic, Electric; date published is 09/16/2009; address is 22 Letchworth Centre Ave , Salter, FN AUSTRALIA, verified against its source on 2026-09-30.
- Firm
- Medec Pty Ltd 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
- AUSTRALIA verified
- Address
- 22 Letchworth Centre Ave , Salter, FN AUSTRALIA verified
- Date published
- 09/16/2009 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric verified
- FDA notes
- MEDEC BioResonance System verified
What the source says
Medec Pty Ltd Date Published : 09/16/2009 22 Letchworth Centre Ave , Salter, FN AUSTRALIA
— 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 and FDA notes
89 I - - SA Massager, Therapeutic, Electric Date Published: 09/16/2009 Notes: MEDEC BioResonance System
— 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.