GENIUS CHIP (SHEN ZHEN) LIMITED · 89-08 · CHINA
For GENIUS CHIP (SHEN ZHEN) LIMITED, 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 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 2026-09-30.
- Firm
- GENIUS CHIP (SHEN ZHEN) LIMITED 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
- Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, CHINA verified
- Date published
- 01/17/2013 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
- Product
- Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms | Bodycomfort EMS Abs and Arms each item verified
- FDA notes
- Class II | class II | class II each item verified
What the source says
GENIUS CHIP (SHEN ZHEN) LIMITED Date Published : 01/17/2013 Xuefu Road, Zhongrun Building A303 , Nanshan District , Shenzhen, 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html