# Zhuzhou Lusong District Hui Tao Electronic Commerc · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhuzhou Lusong District Hui Tao Electronic Commerc · 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 Dr. Fargo Photon Energy Detoxification Bag; product code is 90 M - - UJ System, Planning, Radiation Therapy Treatment; date published is 11/03/2016; address is Carsem Villas NO.1607 , NO. 158 Sports Rd , Zhuzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhuzhou Lusong District Hui Tao Electronic Commerc _(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:** Carsem Villas NO.1607 , NO. 158 Sports Rd , Zhuzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 11/03/2016 _(verified: appears in the quote below)_
- **Product code:** 90 M - - UJ System, Planning, Radiation Therapy Treatment _(verified: appears in the quote below)_
- **Product:** Dr. Fargo Photon Energy Detoxification Bag _(verified: appears in the quote below)_
- **FDA notes:** Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s). _(verified: appears in the quote below)_

## What the source says

> Zhuzhou Lusong District Hui Tao Electronic Commerc Date Published : 11/03/2016 Carsem Villas NO.1607 , NO. 158 Sports Rd , Zhuzhou, CHINA 90 M - - UJ System, Planning, Radiation Therapy Treatment Date Published: 11/03/2016 Desc: Dr. Fargo Photon Energy Detoxification Bag Notes: Class II Device (may be a Class III). The device claims made are varied and the mechanism of technology of the device is and it is unclear how the device produces the intended effects are unclear. CDRH is not aware of any predicate devices that the manufacturer may compare to for 510(k) submission. Therefore; there is no specific product code or regulation that applies to this device since there are no known predicate device(s).

## 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/).