# SHENZHEN SADES DIGITAL TECHNOLOG · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Heyiwei Industrial Park , Shatian Town , Dongguan, CHINA _(verified: appears in the quote below)_
- **Date published:** 06/19/2017 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **Product:** Body Massager | Cupping Therapy Set | Cupping Therapy Set _(verified: each item appears in the quote below)_
- **FDA notes:** Class I device; requires 510(k) | Class I device; requires 510(k) | Class I device; requires 510(k) _(verified: each item appears in the quote below)_

## 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)

## 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/).