SHANGHAI ONETOUCH BUSINESS · 89-08 · CHINA
For SHANGHAI ONETOUCH BUSINESS, 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 H8 Shockwave Massage Machine; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 06/09/2017; address is Room 1219, 1th floor, Building 8 , Guangs , Shanghai, CHINA, verified against its source on 2026-09-30.
- Firm
- SHANGHAI ONETOUCH BUSINESS 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
- Room 1219, 1th floor, Building 8 , Guangs , Shanghai, CHINA verified
- Date published
- 06/09/2017 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric verified
- Product
- H8 Shockwave Massage Machine verified
- FDA notes
- Class I device without a valid 510K verified
What the source says
SHANGHAI ONETOUCH BUSINESS Date Published : 06/09/2017 Room 1219, 1th floor, Building 8 , Guangs , Shanghai, 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: 06/09/2017 Desc: H8 Shockwave Massage Machine Notes: Class I device without a valid 510K
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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