Reference Source

RUNZHAN TECHNOLOGY LIMITED · 89-08 · HONG KONG SAR

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
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 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

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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