SHENZHEN SADES DIGITAL TECHNOLOG · 89-08 · CHINA
For SHENZHEN SADES DIGITAL TECHNOLOG, 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 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 2026-09-30.
- 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
— 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
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)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html