Shenzhen Sheng Yang Kang Technical Co., Ltd. · 89-08 · CHINA
For Shenzhen Sheng Yang Kang Technical Co., Ltd., 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 Detox Ion Foot Cleanse | Detox Ion Foot Cleanse; product code is 89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses; date published is 07/15/2011; address is Longfeng Road , Longgangjiedao Longgang , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Sheng Yang Kang Technical Co., Ltd. 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
- Longfeng Road , Longgangjiedao Longgang , Shenzhen, Guangdong CHINA verified
- Date published
- 07/15/2011 verified
- Product code
- 89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses each item verified
- Product
- Detox Ion Foot Cleanse | Detox Ion Foot Cleanse each item verified
- FDA notes
- CLASS II | CLASS II each item verified
What the source says
Shenzhen Sheng Yang Kang Technical Co., Ltd. Date Published : 07/15/2011 Longfeng Road , Longgangjiedao Longgang , Shenzhen, Guangdong 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 - - LJ Bath, Hydro-Massage Date Published: 07/15/2011 Desc: Detox Ion Foot Cleanse Notes: CLASS II 89 K - - TB Device, Iontophoresis, Specific Uses Date Published: 07/15/2011 Desc: Detox Ion Foot Cleanse 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