Zhuzhou Lusong District Hui Tao Electronic Commerc · 89-08 · CHINA
For Zhuzhou Lusong District Hui Tao Electronic Commerc, 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 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 2026-09-30.
- Firm
- Zhuzhou Lusong District Hui Tao Electronic Commerc 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
- CHINA verified
- Address
- Carsem Villas NO.1607 , NO. 158 Sports Rd , Zhuzhou, CHINA verified
- Date published
- 11/03/2016 verified
- Product code
- 90 M - - UJ System, Planning, Radiation Therapy Treatment verified
- Product
- Dr. Fargo Photon Energy Detoxification Bag verified
- 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
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
— 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, Product and FDA notes
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).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html