# Firma Dinamika Llc. Co. · 89-08 · RUSSIA — FDA import alert red lists: firms subject to detention without physical examination

For Firma Dinamika Llc. Co. · 89-08 · RUSSIA, 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 RUSSIA; product is Fralov's Respiration Training Devices; product code is 80 N - - ZJ Respirator, n95, home use; date published is 03/31/2013; address is 1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA, verified against its source on 2026-09-16.

- **Firm:** Firma Dinamika Llc. Co. _(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:** RUSSIA _(verified: appears in the quote below)_
- **Address:** 1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA _(verified: appears in the quote below)_
- **Date published:** 03/31/2013 _(verified: appears in the quote below)_
- **Product code:** 80 N - - ZJ Respirator, n95, home use _(verified: appears in the quote below)_
- **Product:** Fralov's Respiration Training Devices _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Firma Dinamika Llc. Co. Date Published : 03/31/2013 1-y Parkhomenko Per 14 , Novosibirsk, Novosibirskaya obl RUSSIA 80 N - - ZJ Respirator, n95, home use Date Published: 03/31/2013 Desc: Fralov's Respiration Training 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/).