Shanghai Healeasy Medical Equipment Co Ltd · 89-08 · CHINA
For Shanghai Healeasy Medical Equipment 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 Smart-Wave; Acoustic Wave System; product code is 89 I - - SA Massager, Therapeutic, Electric; date published is 11/03/2017; address is Fl 4 , 2 Yl Lane; Putuo District , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.
- Firm
- Shanghai Healeasy Medical Equipment 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
- Fl 4 , 2 Yl Lane; Putuo District , Shanghai, Shanghai CHINA verified
- Date published
- 11/03/2017 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric verified
- Product
- Smart-Wave; Acoustic Wave System verified
- FDA notes
- Class I device without a valid 510K verified
What the source says
Shanghai Healeasy Medical Equipment Co Ltd Date Published : 11/03/2017 Fl 4 , 2 Yl Lane; Putuo District , Shanghai, 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: 11/03/2017 Desc: Smart-Wave; Acoustic Wave System 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