GENIUS CHIP (SHEN ZHEN) LIMITED · 89-08 · CHINA
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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