YONGKANG JINKANG HEALTH EQUIPMENT FACTORY · 89-08 · CHINA
For YONGKANG JINKANG HEALTH EQUIPMENT FACTORY, 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 Body Massager | Cupping Therapy Set | Cupping Therapy Set; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual; date published is 06/19/2017; address is TONGXI INDUSTRY ZONE , TANGXIAN , Yongkang, ZHEJIANG CHINA, verified against its source on 2026-09-30.
- Firm
- YONGKANG JINKANG HEALTH EQUIPMENT FACTORY 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
- TONGXI INDUSTRY ZONE , TANGXIAN , Yongkang, ZHEJIANG CHINA verified
- Date published
- 06/19/2017 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual each item verified
- Product
- Body Massager | Cupping Therapy Set | Cupping Therapy Set each item verified
- FDA notes
- Class I device; requires 510(k) | Class I device; requires 510(k); | Class I device; requires 510(k); each item verified
What the source says
YONGKANG JINKANG HEALTH EQUIPMENT FACTORY Date Published : 06/19/2017 TONGXI INDUSTRY ZONE , TANGXIAN , Yongkang, ZHEJIANG 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: 06/19/2017 Desc: Body Massager Notes: Class I device; requires 510(k) 89 K - - NM Device, Pressure Applying Date Published: 06/19/2017 Desc: Cupping Therapy Set Notes: Class I device; requires 510(k); 89 L - - YG Massager, Therapeutic, Manual Date Published: 06/19/2017 Desc: Cupping Therapy Set Notes: Class I device; requires 510(k);
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html