# Puretone Ltd. · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Puretone Ltd. · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product code is 77 K - - LW Masker, Tinnitis; date published is 09/16/2009; address is Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Puretone 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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 77 K - - LW Masker, Tinnitis _(verified: appears in the quote below)_
- **FDA notes:** 7/15/2009 Tinnitus Maskers _(verified: appears in the quote below)_

## What the source says

> Puretone Ltd. Date Published : 09/16/2009 Unit 9-10 , Henley Business Park; Trident Close , Rochester, Kent UNITED KINGDOM 77 K - - LW Masker, Tinnitis Date Published: 09/16/2009 Notes: 7/15/2009 Tinnitus Maskers

## 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/).