# Sanbor Medical Xiamen, Inc. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Sanbor Medical Xiamen, Inc. · 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 ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered; date published is 03/01/2011; address is 1776 Lv Ling Road , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.

- **Firm:** Sanbor Medical Xiamen, 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:** CHINA _(verified: appears in the quote below)_
- **Address:** 1776 Lv Ling Road , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 03/01/2011 _(verified: appears in the quote below)_
- **Product code:** 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered _(verified: each item appears in the quote below)_
- **Product:** ReBuilder 300 System; ReBuilder 2407 Personal System | ReBuilder 300 System; ReBuilder 2407 Personal System _(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

> Sanbor Medical Xiamen, Inc. Date Published : 03/01/2011 1776 Lv Ling Road , Xiamen, Fujian CHINA 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System Notes: Class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 03/01/2011 Desc: ReBuilder 300 System; ReBuilder 2407 Personal System 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/).