# RUNZHAN TECHNOLOGY LIMITED · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For RUNZHAN TECHNOLOGY LIMITED · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Breast Massager | Breast Massager | Breast Massager; product code is 79 M - - WZ Expander, Breast, External | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - SA Massager, Therapeutic, Electric; date published is 04/18/2017; address is Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR, verified against its source on 2026-09-16.

- **Firm:** RUNZHAN TECHNOLOGY LIMITED _(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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 04/18/2017 _(verified: appears in the quote below)_
- **Product code:** 79 M - - WZ Expander, Breast, External | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Breast Massager | Breast Massager | Breast Massager _(verified: each item appears in the quote below)_

## What the source says

> RUNZHAN TECHNOLOGY LIMITED Date Published : 04/18/2017 Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR 79 M - - WZ Expander, Breast, External Date Published: 04/18/2017 Desc: Breast Massager 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 04/18/2017 Desc: Breast Massager 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/18/2017 Desc: Breast Massager

## 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/).