SHENZHEN SADES DIGITAL TECHNOLOG · 89-08 · CHINA
For SHENZHEN SADES DIGITAL TECHNOLOG · 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 Body Massager | Cupping Therapy Set | Cupping Therapy Set; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual; date published is 06/19/2017; address is Heyiwei Industrial Park , Shatian Town , Dongguan, CHINA, verified against its source on 2026-09-16.
- Firm
- SHENZHEN SADES DIGITAL TECHNOLOG 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
- Heyiwei Industrial Park , Shatian Town , Dongguan, CHINA verified
- Date published
- 06/19/2017 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual each item verified
- Product
- Body Massager | Cupping Therapy Set | Cupping Therapy Set each item verified
- FDA notes
- Class I device; requires 510(k) | Class I device; requires 510(k) | Class I device; requires 510(k) each item verified
What the source says
SHENZHEN SADES DIGITAL TECHNOLOG Date Published : 06/19/2017 Heyiwei Industrial Park , Shatian Town , Dongguan, CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 06/19/2017 Desc: Body Massager Notes: Class I device; requires 510(k) 89 K - - NM Device, Pressure Applying Date Published: 06/19/2017 Desc: Cupping Therapy Set Notes: Class I device; requires 510(k) 89 L - - YG Massager, Therapeutic, Manual Date Published: 06/19/2017 Desc: Cupping Therapy Set Notes: Class I device; requires 510(k)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.