Shanghai Healeasy Medical Equipment Co Ltd · 89-08 · CHINA
For Shanghai Healeasy Medical Equipment Co Ltd · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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