Mayu Technology Group Co., Ltd. · 89-08 · HONG KONG SAR
For Mayu Technology Group Co., Ltd., import alert is 89-08; country is HONG KONG SAR; 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 Ion Cleanse Massager | Ion Cleanse Massager; product code is 89 I - - LJ Bath, Hydro-Massage | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/13/2012; address is Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Mayu Technology Group 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
- HONG KONG SAR verified
- Address
- Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR verified
- Date published
- 11/13/2012 verified
- Product code
- 89 I - - LJ Bath, Hydro-Massage | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Ion Cleanse Massager | Ion Cleanse Massager each item verified
- FDA notes
- class II | Class II each item verified
What the source says
Mayu Technology Group Co., Ltd. Date Published : 11/13/2012 Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR
— 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 - - LJ Bath, Hydro-Massage Date Published: 11/13/2012 Desc: Ion Cleanse Massager Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/13/2012 Desc: Ion Cleanse Massager 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