Shenzhen Cosmo Catena Co Ltd · 89-08 · CHINA
For Shenzhen Cosmo Catena 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 Stimulator; Nerve; Transcutaneous; For Pain Relief | Stimulator; Nerve; Transcutaneous; For Pain Relief; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - SA Massager, Therapeutic, Electric; date published is 05/16/2014; address is 3201 Kerry Center Renmin South Road Luo , Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Cosmo Catena 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
- 3201 Kerry Center Renmin South Road Luo , Shenzhen, CHINA verified
- Date published
- 05/16/2014 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Stimulator; Nerve; Transcutaneous; For Pain Relief | Stimulator; Nerve; Transcutaneous; For Pain Relief each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Shenzhen Cosmo Catena Co Ltd Date Published : 05/16/2014 3201 Kerry Center Renmin South Road Luo , Shenzhen, 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
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 05/16/2014 Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/16/2014 Desc: Stimulator; Nerve; Transcutaneous; For Pain Relief 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