Reference Source

Shenzhen Oubok Technology Co Ltd · 89-08 · CHINA

For Shenzhen Oubok Technology 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 Foot detox machine | Foot detox machine; product code is 89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses; date published is 06/25/2013; address is 6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA, verified against its source on 2026-09-30.

Firm
Shenzhen Oubok Technology 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
6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, CHINA verified
Date published
06/25/2013 verified
Product code
89 I - - LJ Bath, Hydro-Massage | 89 K - - TB Device, Iontophoresis, Specific Uses each item verified
Product
Foot detox machine | Foot detox machine each item verified
FDA notes
class II | class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shenzhen Oubok Technology Co Ltd Date Published : 06/25/2013 6 F,Block 9, Huafeng Technology Park , Shenzhenshenzhen, 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: 06/25/2013 Desc: Foot detox machine Notes: class II 89 K - - TB Device, Iontophoresis, Specific Uses Date Published: 06/25/2013 Desc: Foot detox machine Notes: class II

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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