# GENIUS CHIP (SHEN ZHEN) LIMITED · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GENIUS CHIP (SHEN ZHEN) LIMITED · 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 Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 01/17/2013; address is Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** GENIUS CHIP (SHEN ZHEN) LIMITED _(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:** Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 01/17/2013 _(verified: appears in the quote below)_
- **Product code:** 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning _(verified: each item appears in the quote below)_
- **Product:** Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | class II | class II _(verified: each item appears in the quote below)_

## What the source says

> GENIUS CHIP (SHEN ZHEN) LIMITED Date Published : 01/17/2013 Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, CHINA 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/17/2013 Desc: Bodycomfort EMS Abs and Arms Notes: Class II 89 L - - YG Massager, Therapeutic, Manual Date Published: 01/17/2013 Desc: Bodycomfort EMS Abs and Arms Notes: class II 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 01/17/2013 Desc: Bodycomfort EMS Abs and Arms Notes: class II

## 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/).