# Shenzhen Oubok Technology Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Oubok Technology Co Ltd · 89-08 · CHINA, 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 CHINA; product is Foot detox machine | Foot detox machine; product code is 89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses; date published is 06/25/2013; address is 6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Oubok Technology Co 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:** CHINA _(verified: appears in the quote below)_
- **Address:** 6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 06/25/2013 _(verified: appears in the quote below)_
- **Product code:** 89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses _(verified: each item appears in the quote below)_
- **Product:** Foot detox machine | Foot detox machine _(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

> Shenzhen Oubok Technology Co Ltd Date Published : 06/25/2013 6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA 89 I - - LJ Bath, Hydro-Massage Date Published: 06/25/2013 Desc: Foot detox machine Notes: class II 89 K - - TB Device, Iontophoresis, Specific Uses Date Published: 06/25/2013 Desc: Foot detox machine 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/).