# XIAN TRIUMPH TECH CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For XIAN TRIUMPH TECH CO LTD · 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 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 2026-09-16.

- **Firm:** XIAN TRIUMPH TECH CO LTD _(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:** Bldg 3 5th Fl , No 4955shangyuan Road , Xi'An, Shaanxi CHINA _(verified: appears in the quote below)_
- **Date published:** 12/12/2022 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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 79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 G - - EX Powered laser surgical instruments Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 N - - RJ Ultrasound, Skin Permeation Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 O - - HV Focused ultrasound for tissue heat or mechanical cellular disruption Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 O - - UP Powered surgical instruments for improvement in the appearance of cellulite Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 O - - YW For the removal of fat through laser lipolysis Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 P - - AY Over-the-counter radiofrequency coagulation device for wrinkle reduction Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 P - - BX Massager, vacuum, radio frequency induced heat Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 P - - ZC Ablation system, high intensity focus ultrasound (HiFU), soft tissue Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 79 P - - ZL Extracorporeal shock wave device for treatment of diabetic foot ulcers Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine 86 Q - - BR Intranasal electrostimulation device for dry eye symptoms Date Published: 12/12/2022 Desc: Sxkeysun Cryolipolysis Slimming Machine

## 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/).