# Medec Pty Ltd · 89-08 · AUSTRALIA — FDA import alert red lists: firms subject to detention without physical examination

For Medec Pty Ltd · 89-08 · AUSTRALIA, 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 AUSTRALIA; 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 2026-09-16.

- **Firm:** Medec Pty Ltd _(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:** AUSTRALIA _(verified: appears in the quote below)_
- **Address:** 22 Letchworth Centre Ave , Salter, FN AUSTRALIA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric _(verified: appears in the quote below)_
- **FDA notes:** MEDEC BioResonance System _(verified: appears in the quote below)_

## What the source says

> Medec Pty Ltd Date Published : 09/16/2009 22 Letchworth Centre Ave , Salter, FN AUSTRALIA 89 I - - SA Massager, Therapeutic, Electric Date Published: 09/16/2009 Notes: MEDEC BioResonance System

## 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/).