Reference Source

RUNZHAN TECHNOLOGY LIMITED · 89-08 · HONG KONG SAR

For RUNZHAN TECHNOLOGY LIMITED, import alert is 89-08; country is HONG KONG SAR; 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)"; 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 2026-09-30.

Firm
RUNZHAN TECHNOLOGY LIMITED verified
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
Address
Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR verified
Date published
04/18/2017 verified
Product code
79 M - - WZ Expander, Breast, External | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Breast Massager | Breast Massager | Breast Massager each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

RUNZHAN TECHNOLOGY LIMITED Date Published : 04/18/2017 Room 1612, 16/F , Taiyau; 181 Johnston Road , Wanchai, HONG KONG SAR

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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