# Cosmo Sonic Inc · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Cosmo Sonic Inc · 89-08 · JAPAN, 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 JAPAN; product is Devices; product code is 89 - - - -- Physical Medicine; date published is 05/14/2014; address is 1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN, verified against its source on 2026-09-16.

- **Firm:** Cosmo Sonic Inc _(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:** JAPAN _(verified: appears in the quote below)_
- **Address:** 1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN _(verified: appears in the quote below)_
- **Date published:** 05/14/2014 _(verified: appears in the quote below)_
- **Product code:** 89 - - - -- Physical Medicine _(verified: appears in the quote below)_
- **Product:** Devices _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Cosmo Sonic Inc Date Published : 05/14/2014 1-17 4 Hongo , Bunkyo-Ku, Tokyo JAPAN 89 - - - -- Physical Medicine Date Published: 05/14/2014 Desc: Devices Notes: Class II

## 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/).