# Sambo Ventec Corp · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Sambo Ventec Corp · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Hyperbaric Oxygen Chamber | Hyperbaric Oxygen Chamber; product code is 73 C - - BF Chamber, Hyperbaric | 79 K - - PJ Chamber, Oxygen, Topical, Extremity; date published is 02/25/2013; address is 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Sambo Ventec Corp _(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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 02/25/2013 _(verified: appears in the quote below)_
- **Product code:** 73 C - - BF Chamber, Hyperbaric | 79 K - - PJ Chamber, Oxygen, Topical, Extremity _(verified: each item appears in the quote below)_
- **Product:** Hyperbaric Oxygen Chamber | Hyperbaric Oxygen Chamber _(verified: each item appears in the quote below)_
- **FDA notes:** class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Sambo Ventec Corp Date Published : 02/25/2013 535-2 Dong Pae Ri Gyo Ha Myen , Paju City Kyung Gi Do, KOREA (THE REPUBLIC OF) 73 C - - BF Chamber, Hyperbaric Date Published: 02/25/2013 Desc: Hyperbaric Oxygen Chamber Notes: class II 79 K - - PJ Chamber, Oxygen, Topical, Extremity Date Published: 02/25/2013 Desc: Hyperbaric Oxygen Chamber 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/).