# Parasym OU · 89-08 · ESTONIA — FDA import alert red lists: firms subject to detention without physical examination

For Parasym OU · 89-08 · ESTONIA, 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 ESTONIA; product is NUROSYM | NUROSYM | NUROSYM | NUROSYM | NUROSYM; product code is 73 B - - XM Stimulator, Nerve, Ac-Powered | 79 M - - DM Instrument, Manual, General Surgical | 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 P - - KR Non-invasive vagus nerve stimulator - headache; date published is 09/11/2023; address is Majaka 26, 11412 , Tallinn, ESTONIA, verified against its source on 2026-09-16.

- **Firm:** Parasym OU _(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:** ESTONIA _(verified: appears in the quote below)_
- **Address:** Majaka 26, 11412 , Tallinn, ESTONIA _(verified: appears in the quote below)_
- **Date published:** 09/11/2023 _(verified: appears in the quote below)_
- **Product code:** 73 B - - XM Stimulator, Nerve, Ac-Powered | 79 M - - DM Instrument, Manual, General Surgical | 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 P - - KR Non-invasive vagus nerve stimulator - headache _(verified: each item appears in the quote below)_
- **Product:** NUROSYM | NUROSYM | NUROSYM | NUROSYM | NUROSYM _(verified: each item appears in the quote below)_

## What the source says

> Parasym OU Date Published : 09/11/2023 Majaka 26, 11412 , Tallinn, ESTONIA 73 B - - XM Stimulator, Nerve, Ac-Powered Date Published: 09/11/2023 Desc: NUROSYM 79 M - - DM Instrument, Manual, General Surgical Date Published: 09/11/2023 Desc: NUROSYM 84 L - - YJ Stimulator, Autonomic Nerve, Implanted for Epilepsy Date Published: 09/11/2023 Desc: NUROSYM 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 09/11/2023 Desc: NUROSYM 84 P - - KR Non-invasive vagus nerve stimulator - headache Date Published: 09/11/2023 Desc: NUROSYM

## 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/).