XIAN TRIUMPH TECH CO LTD · 89-08 · CHINA

For XIAN TRIUMPH TECH CO LTD, import alert is 89-08; country is CHINA; 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 Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine | Sxkeysun Cryolipolysis Slimming Machine; product code is 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories | 79 G - - EX Powered laser surgical instruments | 79 N - - RJ Ultrasound, Skin Permeation | 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite | 79 O - - YW For the removal of fat through laser lipolysis | 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction | 79 P - - BX Massager, vacuum, radio frequency induced heat | 79 P - - ZC Ablation system, high intensity focus ultrasound (HiFU), soft tissue | 79 P - - ZL Extracorporeal shock wave device for treatment of diabetic foot ulcers | 86 Q - - BR Intranasal electrostimulation device for dry eye symptoms; date published is 12/12/2022; address is Bldg 3 5th Fl , No 4955shangyuan Road , Xi'An, Shaanxi CHINA, verified against its source on 2026-09-30.

What the source says

XIAN TRIUMPH TECH CO LTD Date Published : 12/12/2022 Bldg 3 5th Fl , No 4955shangyuan Road , Xi'An, Shaanxi CHINA

— 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.

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

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.